Report Sections

See All Reports

  • COVID-19
  • COVID-19 (39) SARS-CoV-2 (39) vaccine (18) Vaccine (14) Safety (11) Coronavirus (10) Immunogenicity (9) SARS-CoV-2 Vaccine (7) Virus Diseases (6) Ad5 (5) COVID-19 Vaccine (5) COVID-19 vaccine (5) vector vaccine (5) BCG (4) Coronavirus Disease 2019 (4) Covid19 (4) coronavirus (4) COVID (3) COVID 19 (3) Coronavirus infection (3) Covid-19 (3) Dose-escalation (3) Messenger RNA (3) Moderna (3) Protection against COVID-19 (3) RNA Vaccine (3) Recombinant vaccine (3) SARS (3) adenoviral vector (3) mRNA-1273 (3) mRNA-1273 vaccine (3) Ad5-nCoV (2) Adenovirus Vector (2) BCG vaccine (2) COVID-19 Prevention (2) COVID19 (2) ChAdOx1 nCov19 (2) Convalescent plasma (2) DNA vaccine (2) Electroporation (2) Health care workers (2) Immunogencity (2) Passive immunization (2) Prevention (2) Reactogenicity (2) SARS-CoV 2 (2) SARS-CoV-2 infection (2) Severe acute respiratory syndrome coronavirus 2 (2) Sputnik V (2) Tolerability (2) Transfusion (2) covid-19 (2) immunogenicity (2) infectious respiratory diseases (2) novel coronavirus (2) sars-cov-2 (2) 2019 novel coronavirus (1) 2019-nCoV (1) 2019-nCoV (mRNA-1273) (1) ACE2 (1) ARDS (1) AT1 (1) AZD1222 vaccine (1) AZD1222 vaccine for COVID-19 Prevention (1) Ad26 (1) Ad26COVS1 (1) Adenovirus V (1) AlloStim (1) Alvelestat (1) Antibodies, Neutralizing (1) Antibodies, viral/blood (1) Antibody (1) BACILLUS CALMETTE-GUÉRIN VACCINATION (1) BBV152 (1) BCG Vaccination (1) BCG Vaccine (1) Bacille Calmette-Guérin (1) Bacillus Calmette-Guerin (1) Bacillus Calmette-Guérin vaccination (1) Blinded (1) CEPI (1) COVID 19 Vaccine (1) COVID 19 Vaccine Arcturus (1) COVID 2019 (1) COVID-1 (1) COVID-19 infection (1) COVID-19 serotherapy (1) COVID-19, Convalescent plasma therapy (1) COVID-19, SARS-CoV-2 Vaccine (1) COVID-19, Vaccine (1) COVID-2019 (1) COVID19 ( Corona Virus Disease -2019) (1) Clinical trials (1) Coronavirus Infection (1) Coronavirus Infections / therapy (1) Coronavirus Virus Diseases (1) Covid 19 (1) Covid-19 CTL (1) Covid19 Vaccine (1) Covigenix VAX-001 (1) Critically ill COVID-19 patients (1) EGF (1) Endosomal toll-like receptor 3 (1) EpiVacCorona (1) Fibrosis secondary to Covid19 infection (1) Gamaleya (1) Health Workers (1) Healthcare workers (1) Healthy (1) Herpes Zoster (1) Heterologous effects (1) Heterologous prime-boost vaccination (1) Human (1) IFN type1 (1) IFNγ enzyme-linked immune absorbent spot (ELISpot) (1) IN01 vaccine (1) INO-4800 (1) Immunemo (1) Immunemodulation (1) Immunization, Passive (1) Immunoglobulin (1) Immunoglobulin fragments (1) Immunologic Factors (1) Immunology (1) Inactivated SARS-CoV-2 Vaccine (1) Inactivated vaccine (1) Inactive Vaccine (1) Infectiology (1) Infection (1) Innate immune training (1) Interferon Gamma (1) Intranasal Vaccine (1) Intravenous Immunoglobulin (IVIG) (1) Isotretinoin (1) LV-DC vaccine (1) Lentiviral vector (1) Lentiviral vector, Covid-19/aAPC vaccine (1) M-M-R II ® (1) MMR vaccine (1) MMR vaccine, Respiratory failure, (1) MVA (1) Non-specific effects of BCG (1) Pandemics (1) Passive Immunization (1) Phase I (1) Pooled convalescent Plasma (1) QazCovid-in®, vaccine, III phase, efficiency, safety, immunogenicity (1) RNA COVID 19 (1) Randomized controlled (1) Recombinant Novel Coronavirus Vaccine (1) Respiratory disease (1) Retrospective Studies (1) SARS (Severe Acute Respiratory Syndrome) (1) SARS CoV 2 (1) SARS-COV-2 (1) SARS-CoV Infection (1) SARS-CoV-2 (Severe Acute respiratory syndrome Coronavirus 2) (1) SARS-CoV-2-specific serum neutralising antibody titer (1) SARS-CoV-2-surrogate viral neutralising antibody (1) SARS-Cov2 spike protein-binding IgG antibody titer (1) SARS-Cov2 spike protein-specific CD4+ and CD8+ T-cells responses (1) SARS-Cov2 spike protein-specific Th1/Th2 polarisation (1) Sars-Cov-2 Virus Infection (1) Sepsis (1) Severe Acute Respiratory Syndrome (SARS) (1) Severe COVID-19 patients (1) Sputnik (1) Systems Biology (1) T Cells (1) Therapeutic Vaccine (1) Transmission (1) VLA2001 (1) VXA-C0V2-1 (1) Vaccination (1) Vaccinology (1) Vaxart oral vaccine (1) adaptive design (1) adenoviral vector vaccine (1) adenovirus vector (1) adjuvant (1) adult (1) allergy and immunology (1) anti-infective (1) clinical trial (1) corona virus infection (1) coronavirus disease 2019 (1) dendritic cell (1) dose-finding (1) efficacy (1) exploratory efficacy (1) healthy adults (1) healthy elderlies (1) healthy volunteer (1) inactivated vaccine (1) inactivated-adjuvanted Sars-Cov-2 virus vaccine (1) infection (1) inflammation (1) intravenous immunogloulin therapy (1) live attenuated (1) live attenuated vaccine (1) lung disease (1) myeloid-derived suppressor cells (1) novel lipid nanoparticles (LNPs)-encapsulated mRNA-based vaccine (1) off-target effects (1) pandemic (1) passive immunization (1) pneumonia (1) preemptive (1) prevention (1) prophylaxis (1) rAd26-S (1) reactivity (1) respiratory disease (1) safety (1) self amplifying RNA vaccine (1) tablet vaccine (1) therapeutic vaccine (1) tolerability (1) trained immunity (1) trained innate immunity (1) vaccination (1) vaccine, I/II phase, safety, immunogenicity, QazCovid-in® (1) vector (1)

    COVID-19

    This report considers only clinical trials that are associated with COVID-19 vaccines.

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (99)


    Name (Synonyms) Correlation
    drug2490 Placebo Wiki 0.58
    drug1366 Gam-COVID-Vac Wiki 0.36
    drug2805 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki 0.29
    Name (Synonyms) Correlation
    drug3923 mRNA-1273 Wiki 0.28
    drug2529 Placebo Vaccine Wiki 0.23
    drug1592 INO-4800 Wiki 0.18
    drug941 Covigenix VAX-001 placebo Wiki 0.16
    drug3499 Two dose MenACWY vaccine min. 4 weeks apart Wiki 0.16
    drug1586 IMM-101 Wiki 0.16
    drug3947 multipeptide cocktail Wiki 0.16
    drug97 ARCT-021 Dose 1 Wiki 0.16
    drug241 Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) Wiki 0.16
    drug790 Cliniporator Wiki 0.16
    drug2994 Saline-sodium citrate (SSC) buffer Wiki 0.16
    drug2633 Preservative-free saline Wiki 0.16
    drug1367 Gam-COVID-Vac Lyo Wiki 0.16
    drug385 BNT162b2 Wiki 0.16
    drug1130 ERUCOV-VAC Wiki 0.16
    drug103 ARCT-021 single dose priming Wiki 0.16
    drug192 AlloStim Wiki 0.16
    drug581 COVI-VAC Wiki 0.16
    drug4131 vaccine BCG Wiki 0.16
    drug99 ARCT-021 Dose 3 Wiki 0.16
    drug739 ChAdOx1 nCoV-19 single dose + paracetamol Wiki 0.16
    drug1652 Information Wiki 0.16
    drug158 Ad5-nCoV Wiki 0.16
    drug2936 SARS-CoV-2 vaccine (inactivated) Wiki 0.16
    drug2504 Placebo (two doses), priming Wiki 0.16
    drug2002 MenACWY single dose + paracetamol Wiki 0.16
    drug3562 V-SARS Wiki 0.16
    drug2919 SARS-CoV-2 inactivated vaccine Wiki 0.16
    drug1395 Group B (Placebo) Wiki 0.16
    drug740 ChAdOx1 nCoV-19 two dose + paracetamol Wiki 0.16
    drug1394 Group B (AG0302-COVID19) Wiki 0.16
    drug1391 Group A (Placebo) Wiki 0.16
    drug160 AdCOVID Wiki 0.16
    drug1358 GLS-5310 Wiki 0.16
    drug3497 Two dose ChAdOx1 nCoV-19/Covishield 0.5mL Wiki 0.16
    drug1921 MMR vaccine Wiki 0.16
    drug1818 Licensed seasonal influenza vaccine Wiki 0.16
    drug2278 Observation Wiki 0.16
    drug1641 Inactivated SARS CoV 2 vaccine (Vero cell). Wuhan Wiki 0.16
    drug2003 MenACWY vaccine Wiki 0.16
    drug367 BCG vaccine Wiki 0.16
    drug2711 QazCovid-in®-vaccine against COVID-19 Wiki 0.16
    drug1588 IN01 vaccine Wiki 0.16
    drug98 ARCT-021 Dose 2 Wiki 0.16
    drug364 BCG Wiki 0.16
    drug102 ARCT-021 Dose Regimen 2 Wiki 0.16
    drug653 COVID19 vaccine Wiki 0.16
    drug2570 Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine Wiki 0.16
    drug365 BCG GROUP Wiki 0.16
    drug1390 Group A (AG0302-COVID19) Wiki 0.16
    drug736 ChAdOx1 nCoV-19 0.5mL prime plus boost Wiki 0.16
    drug2787 Randomized booster Wiki 0.16
    drug2001 MenACWY prime & saline placebo boost + paracetamol Wiki 0.16
    drug3498 Two dose MenACWY vaccine Wiki 0.16
    drug1585 IL-12 plasmid Wiki 0.16
    drug2924 SARS-CoV-2 rS/Matrix M1-Adjuvant Wiki 0.16
    drug164 Adenovirus Type-5 Vectored COVID-19 Vaccine Wiki 0.16
    drug557 CELLECTRA® 2000 Wiki 0.16
    drug2806 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Wiki 0.16
    drug577 CORVax Wiki 0.16
    drug105 ARCT-021 two lower dose priming Wiki 0.16
    drug101 ARCT-021 Dose Regimen 1 Wiki 0.16
    drug734 ChAdOx1 nCoV-19 (qPCR) Wiki 0.16
    drug104 ARCT-021 two higher dose priming Wiki 0.16
    drug2254 Normal saline 0.9% Wiki 0.16
    drug3987 oral polio vaccine + information Wiki 0.16
    drug733 ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost Wiki 0.16
    drug732 ChAdOx1 nCoV-19 (Abs 260) Wiki 0.16
    drug2382 PLACEBO GROUP Wiki 0.16
    drug3422 Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine Wiki 0.16
    drug623 COVID-19 convalescent plasma Wiki 0.16
    drug1643 Inactivated SARS-CoV-2 vaccine (Vero cell) Wiki 0.16
    drug100 ARCT-021 Dose 4 Wiki 0.16
    drug928 Covax-19™ Wiki 0.16
    drug159 AdCLD-CoV19 Wiki 0.16
    drug3496 Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL Wiki 0.16
    drug1364 GX-19 Wiki 0.16
    drug2777 RUTI® vaccine Wiki 0.16
    drug2530 Placebo booster Wiki 0.16
    drug940 Covigenix VAX-001 Wiki 0.16
    drug2985 Saline Wiki 0.14
    drug2930 SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki 0.11
    drug731 ChAdOx1 nCoV-19 Wiki 0.11
    drug899 Convalescent plasma Wiki 0.11
    drug4042 rAd26-S Wiki 0.11
    drug678 CVnCoV Vaccine Wiki 0.11
    drug3523 UB-612 Wiki 0.11
    drug80 AG0301-COVID19 Wiki 0.11
    drug4004 placebo Wiki 0.09
    drug1642 Inactivated SARS-CoV-2 Vaccine (Vero cell) Wiki 0.09
    drug81 AG0302-COVID19 Wiki 0.09
    drug157 Ad26.COV2.S Wiki 0.09
    drug384 BNT162b1 Wiki 0.09
    drug3574 VPM1002 Wiki 0.09
    drug366 BCG Vaccine Wiki 0.08
    drug128 AZD1222 Wiki 0.07

    Correlated MeSH Terms (16)


    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.38
    D007239 Infection NIH 0.35
    D045169 Severe Acute Respiratory Syndrome NIH 0.33
    Name (Synonyms) Correlation
    D000257 Adenoviridae Infections NIH 0.21
    D014777 Virus Diseases NIH 0.20
    D005355 Fibrosis NIH 0.16
    D006331 Heart Diseases NIH 0.16
    D029424 Pulmonary Disease, Chronic Obstructive NIH 0.16
    D018746 Systemic Inflammatory Response Syndrome NIH 0.16
    D014115 Toxemia NIH 0.16
    D018805 Sepsis NIH 0.16
    D003327 Coronary Disease NIH 0.16
    D008173 Lung Diseases, Obstructive NIH 0.16
    D011658 Pulmonary Fibrosis NIH 0.16
    D012141 Respiratory Tract Infections NIH 0.08
    D003141 Communicable Diseases NIH 0.07

    Correlated HPO Terms (5)


    Name (Synonyms) Correlation
    HP:0002206 Pulmonary fibrosis HPO 0.16
    HP:0006510 Chronic pulmonary obstruction HPO 0.16
    HP:0006536 Pulmonary obstruction HPO 0.16
    Name (Synonyms) Correlation
    HP:0100806 Sepsis HPO 0.16
    HP:0011947 Respiratory tract infection HPO 0.08

    Clinical Trials

    Navigate: Correlations   HPO

    There are 39 clinical trials


    1 Randomized, Double Blind, Placebo Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Argentine Healthy Population Aged Between 18 and 85 Years

    This is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.

    NCT04560881
    Conditions
    1. COVID-19 Virus Infection
    Interventions
    1. Biological: Inactivated SARS-CoV-2 vaccine (Vero cell)
    2. Biological: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine
    MeSH:Virus Diseases

    Primary Outcomes

    Description: All confirmed COVID -19 cases 14 days after the full course of vaccination among healthy population aged between 18 and 85 years old.

    Measure: Incidence of COVID-19 cases after two-doses of vaccination

    Time: 14 days after the full course of vaccination

    Secondary Outcomes

    Measure: The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    Time: 14 days after 2-dose of immunization and 28 days after full course of immunization

    Measure: The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Time: 14 days after 2-dose of immunization and 28 days after full course of immunization

    Measure: The Geometric Mean Increase (GMI) of anti-SARS-CoV-2 neutralizing antibody

    Time: 14 days after 2-dose of immunization and 28 days after full course of immunization

    Measure: Incidence of any adverse reactions/events

    Time: Within 30 minutes after each dose of vaccine

    Measure: Incidence of adverse reactions/events

    Time: 0 ~ 21/28 days after each dose of vaccine

    Measure: Incidence of serious adverse events (SAE)

    Time: From the beginning of the first dose to 12 months after the whole course of immunization

    Other Outcomes

    Description: The protective level of Anti-SARS-CoV-2 NtAbs

    Measure: Anti-SARS-CoV-2 neutralizing antobody (NtAb) (immunological surrogate endpoint)

    Time: 14 days after 2-dose of immunization.
    2 A Phase II Open-label Study in Adults to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, Given in Combination With rAd26-S, Recombinant Adenovirus Type 26 Component of Gam-COVID-Vac Vaccine, for the Prevention of COVID 19

    The primary objective of this study is to describe the safety and tolerability of one IM dose of AZD1222 followed by one IM dose of rAd26-S in adults ≥ 18 years of age

    NCT04686773
    Conditions
    1. COVID-19
    Interventions
    1. Biological: AZD1222
    2. Biological: rAd26-S
    MeSH:Adenoviridae Infections

    Primary Outcomes

    Description: Incidence of Serious Adverse Events (SAEs) post first dose until the study end

    Measure: Incidence of Serious Adverse Events (SAEs) post first dose until the study end

    Time: from Day 1 until Day 180

    Secondary Outcomes

    Description: Incidence of unsolicited AEs for 28 days post each dose

    Measure: Incidence of unsolicited Adverse Events (AEs) for 28 days post each dose

    Time: from Day 1 to Day 28 and from Day 29 to Day 57

    Description: Incidence of local and systemic solicited AEs for 7 days post each dose

    Measure: Incidence of local and systemic solicited AEs for 7 days post each dose

    Time: from Day 1 to Day 8 and From Day 29 to Day 36

    Description: Incidence of AESIs post first dose until study end (Day 180)

    Measure: Incidence of Adverse events of special interest (AESIs) post first dose until study end

    Time: from Day 1 to Day 180

    Description: assessment of time course of antibody to Spike protein of one IM dose of AZD1222 followed by one IM dose of rAd26-S

    Measure: assessment of time course of antibody to Spike protein of one IM dose of AZD1222 followed by one IM dose of rAd26-S

    Time: On Day 1 and on Day 29

    Description: Determination of anti-SARS-CoV-2 neutralising antibody levels in serum following one IM dose of AZD1222 followed by one IM dose of rAd26-S

    Measure: Determination of anti-SARS-CoV-2 neutralising antibody levels in serum following one IM dose of AZD1222 followed by one IM dose of rAd26-S

    Time: On Day 1 and on day 29

    Description: Proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titers from day of dosing baseline value to 28 days post each dose) as measured by SARS-CoV-2 antibodies to Spike protein

    Measure: Proportion of participants who have a post treatment seroresponse

    Time: from Day 1 (before dose) to Day 28 and from Day 29 (before dose) to Day 57
    3 Reducing Hospital Admission of Elderly in SARS-CoV-2 Pandemic Via the Induction of Trained Immunity by Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial

    Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also been shown to induce protection against various infections with a viral aetiology, leading to significant reductions in morbidity and mortality. We hypothesize that BCG vaccination might be a potent preventive measure against SARS-CoV-2 infection and/or may reduce disease severity in elderly people, who are known to be at increased risk of illness and death from SARS-CoV-2 infection. Therefore, we will in this placebo-controlled adaptive multi-centre randomized controlled trial evaluate the ability of BCG to reduce hospital admission and its efficacy to improve the clinical course of SARS-CoV-2 infection in elderly people((≥ 60 years of age).

    NCT04417335
    Conditions
    1. COVID-19
    Interventions
    1. Biological: BCG vaccine
    2. Biological: Placebo

    Primary Outcomes

    Measure: SARS-CoV-2 related hospital admission

    Time: Maximum of 1 year

    Secondary Outcomes

    Measure: the duration of hospital admission due to documented COVID-19

    Time: Maximum of 1 year

    Measure: the cumulative incidence of documented SARS-CoV-2 infection

    Time: Maximum of 1 year

    Measure: the cumulative incidence of self-reported acute respiratory symptoms or fever

    Time: Maximum of 1 year

    Measure: the cumulative incidence of death due to documented SARS-CoV-2 infection

    Time: 1 year

    Measure: the cumulative incidence of hospital admission for any reason

    Time: Maximum of 1 year

    Measure: the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection

    Time: Maximum of 1 year
    4 A Randomized Clinical Trial for Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination to Prevent Infections by COVID-19: The ACTIVATE II Trial

    Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied

    NCT04414267
    Conditions
    1. COVID-19
    2. Virus Diseases
    3. Corona Virus Infection
    4. Coronary Heart Disease
    5. Chronic Obstructive Pulmonary Disease
    Interventions
    1. Biological: BCG vaccine
    2. Biological: Placebo
    MeSH:Infection Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Heart Diseases Coronary Disease
    HPO:Chronic pulmonary obstruction Pulmonary obstruction

    Primary Outcomes

    Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2

    Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3.

    Time: Visit 3 (90 +/- 5 days)

    Secondary Outcomes

    Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4

    Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4

    Time: Visit 4 (135 +/- 5 days)

    Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5

    Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5

    Time: Visit 5 (180 +/- 5 days)

    Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled

    Measure: Prevalence of IgG/IgM against SARS-CoV-2

    Time: Screening Visit and Visit 3 (90 +/- 5 days)

    Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit

    Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19.

    Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.

    Measure: The impact of new cardiovascular events between the two study groups

    Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

    Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

    Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

    Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

    Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

    Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

    Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

    Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

    Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

    Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

    Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

    Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

    Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.

    Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed

    Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)
    5 A Randomized, Double-blind, Placebo -Controlled Phase IIb Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV in Person 6 Years of Age and Older and Those Who Have Previously Been Vaccinated With Ad5-EBOV

    This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .

    NCT04566770
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    2. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo

    Primary Outcomes

    Description: Occurrence of adverse reactions post vaccination

    Measure: Safety indexes of adverse reactions

    Time: within 14 days post each vaccination

    Description: Evaluate the Geometric mean titer (GMT) of IgG antibody

    Measure: Immunogencity indexes of GMT

    Time: Day 28 post the second vaccination

    Description: Evaluate the Geometric mean titer (GMT) of neutralizing antibody

    Measure: Immunogencity indexes of neutralizing antibody

    Time: Day 28 post the second vaccination

    Secondary Outcomes

    Description: Occurrence of adverse reactions post-vaccination

    Measure: Safety indexes of adverse events

    Time: Day 0-7,0-14,0-28 post each vaccination

    Description: Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)

    Measure: Safety indexes of Hematological examination measures(Hemoglobin, WBC)

    Time: pre-vaccination, day 4 post each vaccination

    Description: Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)

    Measure: Safety indexes of Blood routine measures(ALT, AST)

    Time: pre-vaccination, day 4 post each vaccination

    Description: Occurrence of serious adverse events post-vaccination

    Measure: Safety indexes of SAE

    Time: Within 6 months post the second vaccination

    Description: Evaluate the Geometric mean titer of IgG antibody

    Measure: Immunogencity indexes of GMT

    Time: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination

    Description: Evaluate the Geometric mean titer (GMT) of neutralizing antibody

    Measure: Immunogencity indexes of neutralizing antibody

    Time: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination

    Description: Number of cell-mediated immune response against SARS-CoV-2(IL-2)

    Measure: Immunogencity indexes of cellular immune

    Time: Day 28 post the first vaccination, pre and day 28 post the second vaccination
    6 Phase 1 Study for the Determination of Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID 19 Vaccine ERUCOV-VAC, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design.

    The objective is to determine the safety and immunogenicity of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19.

    NCT04691947
    Conditions
    1. COVID-19 Vaccine
    Interventions
    1. Biological: ERUCOV-VAC
    2. Other: Placebo Vaccine

    Primary Outcomes

    Description: The number and proportion of subjects with adverse events observed until Day 43 post 1st vaccination are declared to be primary target variables.

    Measure: To assess the safety and tolerability of the COVID-19 vaccine

    Time: 43 days

    Secondary Outcomes

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s).

    Measure: Specific antibody response induced by the vaccine against the SARS-CoV-2 virus

    Time: 12 months

    Description: Serum Neutralizing antibody levels.

    Measure: Neutralizing Antibodies Levels

    Time: 12 months

    Description: Serum TNF-alpha levels.

    Measure: TNF-alpha Levels

    Time: 12 months

    Description: Serum IFN-γ levels.

    Measure: Interferon Levels

    Time: 12 months

    Description: Serum IL-2, -4, -5, -6 levels.

    Measure: Interleukine Levels

    Time: 12 months
    7 Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020

    Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses. Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them. For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.

    NCT04362124
    Conditions
    1. COVID-19
    Interventions
    1. Biological: vaccine BCG
    2. Other: Placebo
    MeSH:Infection

    Primary Outcomes

    Description: Incidence of COVID-19 cases confirmed or probable in the study population

    Measure: Primary outcome

    Time: From date of randomization to 360 day of the study

    Secondary Outcomes

    Description: Incidence of severe or critical infection in COVID-19 cases

    Measure: Secondary outcome

    Time: From date to diagnosis to 1 month after

    Description: Lethality of the infection in both groups

    Measure: Secondary outcome

    Time: From date to diagnosis to 1 month after

    Description: Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination

    Measure: Secondary outcome

    Time: From date of randomization to 7 day of the study

    Description: Prevalence of SARS-Cov-2 infection

    Measure: Secondary outcome

    Time: At baseline evaluation
    8 A Single-center,Open-label,Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old

    The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .

    NCT04313127
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

    Primary Outcomes

    Description: Occurrence of adverse reactions post-vaccination

    Measure: Safety indexes of adverse reactions

    Time: 0-7 days post-vaccination

    Secondary Outcomes

    Description: Occurrence of adverse events post-vaccination

    Measure: Safety indexes of adverse events

    Time: 0-28 days post-vaccination

    Description: Occurrence of serious adverse events post-vaccination

    Measure: Safety indexes of SAE

    Time: 0-28 days, within 6 mouths post-vaccination

    Description: Occurrence of abnormal changes of laboratory safety examinations

    Measure: Safety indexes of lab measures

    Time: pre-vaccination, day 7 post-vaccination

    Description: Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

    Measure: Immunogencity indexes of GMT(ELISA)

    Time: day14,28,month 3,6 post-vaccination

    Description: Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

    Measure: Immunogencity indexes of GMT(pseudoviral neutralization test method)

    Time: day14,28,month 6 post-vaccination

    Description: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

    Measure: Immunogencity indexes of seropositivity rates(ELISA)

    Time: day14,28,month 3,6 post-vaccination

    Description: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

    Measure: Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method)

    Time: day14,28,month 6 post-vaccination

    Description: Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

    Measure: Immunogencity indexes of GMI(ELISA)

    Time: day14,28,month 3,6 post-vaccination

    Description: Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

    Measure: Immunogencity indexes of GMI(pseudoviral neutralization test method)

    Time: day14,28,month 6 post-vaccination

    Description: Geometric mean concentration(GMC)of anti-Ad5 vector neutralizing antibody responses

    Measure: Immunogencity indexes of GMC(Ad5 vector)

    Time: day、14,28,month3,6 post-vaccination

    Description: Geometric mean fold increase(GMI)of anti-Ad5 vector neutralizing antibody responses

    Measure: Immunogencity indexes of GMI(Ad5 vector)

    Time: day、14,28,month3,6 post-vaccination

    Description: specific cellular immune responses

    Measure: Immunogencity indexes of cellular immune

    Time: day 14, 28,month 6 post-vaccination

    Other Outcomes

    Description: Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method

    Measure: Consistency analysis(ELISA and pseudoviral neutralization test method)

    Time: day,14,28, month 6 post-vaccination

    Description: Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups

    Measure: Dose-response relationship(Humoral immunity)

    Time: day14,28,month 3,6 post-vaccination

    Description: Persistence analysis of anti-S protein antibodies among study groups

    Measure: Persistence analysis of anti-S protein antibodies

    Time: day14,28,month 3,6 post-vaccination

    Description: Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.

    Measure: Time-dose-response relationship(Humoral immunity)

    Time: day14,28,month 3,6 post-vaccination

    Description: Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups

    Measure: Dose-response relationship( cellular immunity)

    Time: day 14, 28,month 6 post-vaccination

    Description: Persistence analysis of specific cellular immune response

    Measure: Persistence analysis of cellular immuse

    Time: day 14, 28,month 6 post-vaccination

    Description: Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.

    Measure: Time-dose-response relationship(cellular immunity)

    Time: day 14, 28,month 6 post-vaccination
    9 COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement

    To date, there is no vaccine or treatment with proven efficiency against COVID-19, and the transmissibility of the SARS-CoV-2 virus can be inferred by its identification in the oro-nasopharynx. The bacillus Calmette Guérin (BCG) has the potential for cross-protection against viral infections. This study evaluates the impact of previous (priming effect, from the titer of anti-BCG interferon-gamma) or current BCG exposure (boost with intradermal vaccine) on 1) clinical evolution of COVID-19; 2) elimination of SARS-CoV-2 at different times and disease phenotypes; and 3) seroconversion rate and titration (anti-SARS-CoV-2 IgA, IgM, and IgG).

    NCT04369794
    Conditions
    1. COVID-19
    2. Therapeutic Vaccine
    3. BCG
    4. SARS-CoV 2
    5. Transmission
    Interventions
    1. Biological: BCG
    2. Biological: Placebo

    Primary Outcomes

    Description: Classified as mild, moderate and severe

    Measure: Clinical evolution of COVID-19

    Time: 45 days of symptoms onset or diagnosis

    Description: Virus detection by PCR

    Measure: SARS-CoV-2 elimination

    Time: 7 days of symptoms onset or diagnosis

    Description: Titration of anti SARS-CoV-2 IgA, IgM and IgG

    Measure: Seroconversion rate and titration

    Time: 7 days of symptoms onset or diagnosis

    Secondary Outcomes

    Description: Classified according to type and severity

    Measure: Local and systemic adverse events to BCG vaccination

    Time: 3 months

    Other Outcomes

    Description: Virus detection by PCR

    Measure: SARS-CoV-2 elimination

    Time: 21 days of symptoms onset or diagnosis

    Description: Titration of anti SARS-CoV-2 IgA, IgM and IgG

    Measure: Seroconversion rate

    Time: 21 days of symptoms onset or diagnosis

    Description: Virus detection by PCR

    Measure: SARS-CoV-2 elimination

    Time: 45 days of symptoms onset or diagnosis

    Description: Titration of anti SARS-CoV-2 IgA, IgM and IgG

    Measure: Seroconversion rate and titration

    Time: 45 days of symptoms onset or diagnosis
    10 Randomized, Double-blind, Placebo Controlled, Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Combined Vector Vaccine in Prophylactic Treatment for SARS-СoV-2 Infection

    Randomized, double-blind, placebo controlled clinical trial of immunogenicity, safety and efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults.

    NCT04642339
    Conditions
    1. Covid19
    Interventions
    1. Biological: Gam-COVID-Vac
    2. Biological: Placebo

    Primary Outcomes

    Description: Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose

    Measure: Seroconversion rate

    Time: 42 day, 180 day

    Secondary Outcomes

    Description: Incidence and severity of adverse events in trial subjects within 6 months after injecting the first dose of the study drug/placebo

    Measure: Incidence and severity of adverse events

    Time: through the study (till day 180)

    Description: Geometric mean virus-neutralizing antibodies titer in 500 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose

    Measure: Virus-neutralizing antibody levels against the SARS-CoV-2

    Time: 42 day

    Description: Geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose

    Measure: Antibody levels against the SARS-CoV-2 glycoprotein

    Time: 42 day, 180 day

    Description: Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months, as confirmed with the method of polymerase chain reaction (PCR)

    Measure: Percentage of trial subjects with coronavirus disease 2019 (COVID-19)

    Time: through the study (till day 180)
    11 A Phase I Trial of a Therapeutic Vaccine (Covax-19™) in SARS-CoV-2 Infected Patients

    GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed for safety through week 26.

    NCT04428073
    Conditions
    1. COVID
    Interventions
    1. Biological: Covax-19™

    Primary Outcomes

    Description: Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations.

    Measure: To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities.

    Time: 26 weeks

    Secondary Outcomes

    Description: Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations.

    Measure: To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response

    Time: 6 weeks

    Description: Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4.

    Measure: Virologic response after vaccination

    Time: 4 weeks

    Description: Number of participants with moderate, severe or critical Covid-19 at week 6.

    Measure: Clinical outcome and progression after vaccinations

    Time: 6 weeks
    12 An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" a Solution for Intramuscular Injection With the Participation of Healthy Volunteers

    The purpose of the study is to assess safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of healthy volunteers Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using single dose of each component (Stage 1). A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2). Post-vaccination immunity assessment at different time points after vaccination by: - Determination of antigen-specific antibody titer in blood serum by ELISA by comparison with baseline values before the vaccine administration and at days 14, 21, 28, and 42 after vaccination (hereinafter, the countdown comes from the first time of the vaccine administration); - Determination of virus neutralizing antibody titer before and at days 14, 28, and 42 after vaccination; - Determination of antigen-specific cellular immunity (specific T-cell immunity) before the vaccine administration and at days 14 and 28 after vaccination.

    NCT04436471
    Conditions
    1. Preventive Immunization COVID-19
    Interventions
    1. Biological: Gam-COVID-Vac

    Primary Outcomes

    Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values

    Measure: Changing ofantibody levels against the SARS-CoV-2 glycoprotein S in 42 days

    Time: at days 0,14, 21, 28, 42

    Description: Determination of Number of Participants With Adverse Events

    Measure: Number of Participants With Adverse Events

    Time: through the whole study, an average of 180 days

    Secondary Outcomes

    Description: Determination of virus neutralizing antibody titer

    Measure: Changing of of virus neutralizing antibody titer

    Time: at days 0,14, 28, 42

    Description: Determination of antigen-specific cellular immunity (specific T-cell immunityin particular, IFN-gamma production or lymphoproliferation)

    Measure: Changing of antigen-specific cellular immunity level

    Time: at days 0,14, 42
    13 Use of a Live Attenuated Vaccine Repurposed as an Innate Immune-based Preventive Against COVID-19-associated Sepsis/Inflammation

    The objective of this randomized clinical trial is to test whether administration of live attenuated MMR vaccine (measles mumps rubella; Merck) to eligible adults at highest risk for contracting COVID-19 (healthcare workers, first responders), can induce non-specific trained innate immune leukocytes that can prevent/dampen pathological inflammation and sepsis associated with COVID-19-infection, if exposed.

    NCT04475081
    Conditions
    1. Sepsis Syndrome
    Interventions
    1. Biological: MMR vaccine
    MeSH:Sepsis Toxemia Systemic Inflammatory Response Syndrome
    HPO:Sepsis

    Primary Outcomes

    Description: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

    Measure: Induction of myeloid-derived suppressor cells (MDSCs)

    Time: 14 days post-vaccination

    Description: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

    Measure: Induction of MDSCs

    Time: 30 days post vaccination

    Description: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

    Measure: Induction of MDSCs

    Time: 60 days post vaccination

    Description: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

    Measure: Induction of MDSCs

    Time: 12 months post vaccination

    Secondary Outcomes

    Description: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

    Measure: COVID-19 infection positive

    Time: 14 days post-vaccination

    Description: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

    Measure: COVID-19 infection positive

    Time: 30 days post-vaccination

    Description: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

    Measure: COVID-19 infection positive

    Time: 60 days post-vaccination

    Description: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

    Measure: COVID-19 infection positive

    Time: 12 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 14 days post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 30 days post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 60 days post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 3 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 4 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 5 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 6 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 7 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 8 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 9 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 10 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 11 months post-vaccination

    Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

    Measure: Health questionnaire

    Time: 12 months post-vaccination
    14 An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac Lyo" Lyophilizate for the Preparation of a Solution for Intramuscular Injection With the Participation of Healthy Volunteers

    the purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular administration, at various times after vaccination in healthy adult volunteers.

    NCT04437875
    Conditions
    1. Preventive Immunization COVID-19
    Interventions
    1. Biological: Gam-COVID-Vac Lyo

    Primary Outcomes

    Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values

    Measure: The changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days

    Time: at days 0, 14, 21, 28, 42

    Description: Determination of Number of Participants With Adverse Events

    Measure: Number of Participants With Adverse Events

    Time: through the whole study, an average of 180 days

    Secondary Outcomes

    Description: Determination of virus neutralizing antibody titer

    Measure: The changing of virus neutralizing antibody titer

    Time: at days 0, 14, 28, 42

    Description: Determination of antigen-specific cellular immunity (specific T-cell immunity, in particular, IFN-gamma production or lymphoproliferation)

    Measure: The changing of antigen-specific cellular immunity level

    Time: at days 0, 14, 28
    15 A Randomized, Observer-Blind, Dose-escalation Phase I/II Clinical Trial of Ad5-nCoV Vaccine in Healthy Adults From 18 to <85 Years of Age in Canada

    This study is a phase I /II adaptive clinical trial to evaluate the safety, tolerability and the Immunogenicity of Ad5-nCoV in healthy adults from 18 to <55 and 65 to <85 years of age,with the randomized, observer-blind, dose-escalation design

    NCT04398147
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    2. Biological: Placebo

    Primary Outcomes

    Description: The occurrence of Solicited AE in all groups within 0-6 days after each vaccination;

    Measure: Incidence of the Solicited AE in all groups

    Time: 0-6 days after each vaccination

    Description: The occurrence of Unsolicited AE in all groups within 0-28 days after each vaccination.

    Measure: Incidence of Unsolicited AE in all groups

    Time: 0-28 days after each vaccination

    Description: The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.

    Measure: Incidence of Serious adverse events (SAE) in all groups

    Time: 6 months after the final vaccination

    Secondary Outcomes

    Description: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);

    Measure: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 (ELISA method);

    Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Seroconversion rate (%of subjects with 4-fold or greater increase in antibody level) of the IgG antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method );

    Measure: Seroconversion rate of the IgG antibody against SARS-CoV-2(ELISA method )

    Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);

    Measure: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2(ELISA method);

    Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)

    Measure: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)

    Time: Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group(Pseudo-viral neutralization assay);

    Measure: Seroconversion rate of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)

    Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)

    Measure: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 (Pseudo-viral neutralization assay)

    Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group;

    Measure: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector

    Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Measure: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector

    Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot

    Measure: cellular immune response by ELISpot

    Time: on Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

    Description: The positive rate of IFN-γ, TNF-α, and IL-2 expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by Intracellular Cytokine Staining (ICS);

    Measure: cellular immune response by ICS

    Time: Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group
    16 Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill

    Safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.

    NCT04380532
    Conditions
    1. Covid19
    Interventions
    1. Biological: V-SARS

    Primary Outcomes

    Description: Routine laboratory complete blood cell count at pre- and post-treatment periods by automated CBC counter Routine laboratory complete blood count Routine clinical laboratory CBC parameters at pre- and post-treatment periods

    Measure: Effect on CBC as per CTCAE v4.0

    Time: 15 Days

    Description: Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer

    Measure: Effect on biochemistry parameters as per CTCAE v4.0

    Time: 15 Days

    Secondary Outcomes

    Description: Clinical well-being assessed by CTCAE v4.0

    Measure: Lack of adverse events as per CTCAE v4.0

    Time: 15 days
    17 A Global Multicenter, Randomized, Double-blind, Placebo -Controlled, Adaptive Designed Phase Ⅲ Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Ad5-nCoV in Adults 18 Years of Age and Older

    This study is a global multicenter, randomized, double-blind, placebo -controlled, adaptive designed phase Ⅲ clinical trial, in order to evaluate the efficacy, safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years old and above.

    NCT04526990
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    2. Biological: Placebo

    Primary Outcomes

    Description: The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease

    Measure: Incidence of COVID-19 cases

    Time: day 28 to 12 months post vaccination

    Description: Evaluate the incidence of severe adverse events (SAE)

    Measure: Incidence of SAE

    Time: Within 12 months

    Secondary Outcomes

    Description: Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection

    Measure: Incidence of severe COVID-19 cases

    Time: Day 14 to 12 months post vaccination

    Description: Incidence of solicited adverse reactions within 7 days after vaccination, in a subset

    Measure: Incidence of solicited adverse reactions

    Time: Day 0-7 post vaccination

    Description: Incidence of unsolicited adverse events within 28 days after vaccination in a subset

    Measure: Incidence of unsolicited adverse events

    Time: Day 0-28 post vaccination

    Description: The seroconversion rate of S-RBD IgG antibody post vaccination

    Measure: Immunogencity of S-RBD IgG antibody (ELISA method)

    Time: Day 28 post vaccination

    Description: The seroconversion rate of neutralizing antibody

    Measure: Immunogencity of neutralizing antibody

    Time: Day 28 post vaccination

    Description: Number of cell-mediated immune response against SARS-CoV-2

    Measure: Cell-mediated immune profile

    Time: Day 28 post vaccination
    18 Phase I/II Trial to Evaluate Safety, Tolerability, Immunogenicity of a Prophylactic Plasmid DNA Vaccine for SARS CoV-2 [Covigenix VAX-001] in Healthy Adults From 18 to <85 Years of Age

    This is a phase I/II, placebo-controlled, randomized, observer-blind, dose ranging adaptive clinical trial in males and non-pregnant females, 18 to <55 and 65 to <85 years of age, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, immunogenicity and efficacy of Covigenix VAX-001 manufactured by Entos Pharmaceuticals.

    NCT04591184
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: Covigenix VAX-001 placebo
    2. Biological: Covigenix VAX-001

    Primary Outcomes

    Description: Frequency and Grade (mild, moderate, severe, potentially life-threatening; Gr. 1-4, respectively) of solicited injection site and systemic adverse events and unsolicited systemic adverse events

    Measure: Safety of a 2-dose regimen of VAX-001 when doses are given 14 days apart

    Time: Up to Day 42

    Description: Adverse hematology /clinical chemistry parameter changes (mild, moderate, severe, or life-threatening; Gr. 1-4, respectively)

    Measure: Mean change from baseline in safety laboratory measures

    Time: Days 0-42

    Description: Frequency of serious AEs

    Measure: Frequency of treatment-emergent Serious Adverse Events (SAE) throughout the study and up to 6 months post-second dose immunization (Day 196).

    Time: Days 0-196

    Secondary Outcomes

    Description: Percent seroconversion post second dose as measured by ELISA

    Measure: Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by IgG ELISA

    Time: Up to Day 196

    Description: Geometric mean of antibody titers measured by pseudo-viral neutralization assay.

    Measure: Geometric mean neutralizing antibody titers against pseudo-virion after one and two doses

    Time: Up to Day 196

    Description: Seroconversion as measured by pseudo-viral neutralization

    Measure: Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by pseudo-viral neutralization assay.

    Time: up to Day 196

    Description: Maintenance of antibody titers up to Six months post second dose

    Measure: Persistence of IgG antibody titers as measured by ELISA and neutralizing antibody titers measured by pseudo-virion neutralization assay, six months after the second vaccine dose

    Time: Up to Day 196
    19 Сlinical Trial of Efficacy, Safety and Immunogenicity of Combined Vector Vaccine Gam-COVID-Vac in SARS-СoV-2 Infection Prophylactic Treatment in Republic of Belarus

    Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

    NCT04564716
    Conditions
    1. Covid19
    Interventions
    1. Biological: Gam-COVID-Vac
    2. Other: Placebo

    Primary Outcomes

    Description: Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)

    Measure: percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose

    Time: through the whole study, an average of 180 days

    Secondary Outcomes

    Description: Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19

    Measure: the severity of the clinical course of COVID-19

    Time: through the whole study, an average of 180 days

    Description: Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies

    Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S

    Time: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose

    Description: Incidence of adverse events in trial subjects compared to placebo

    Measure: Incidence of adverse events in trial subjects

    Time: through the whole study, an average of 180 days

    Description: Severity of adverse events in trial subjects compared to placebo

    Measure: Severity of adverse events in trial subjects

    Time: through the whole study, an average of 180 days
    20 Multicenter, Randomized, Combined Phase I Dose-escalation and Phase IIa Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Immunogenicity of GLS-5310 DNA Vaccine, Administered Intradermally Against SARS-CoV-2 in Healthy Adults

    This clinical trial will evaluate the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2(COVID-19) in healthy volunteers.

    NCT04673149
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: GLS-5310
    2. Biological: Placebo

    Primary Outcomes

    Description: solicited/unsolicited local and systemic AEs after vaccination

    Measure: Incidence of adverse events

    Time: Through 48 weeks post vaccination

    Description: Endpoint titer of binding antibody in serum

    Measure: Geometric mean titer (GMT) of antigen-specific binding antibody titers

    Time: Through 48 weeks post vaccination

    Secondary Outcomes

    Description: T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint

    Measure: Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine

    Time: Through 48 weeks post vaccination

    Description: Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint

    Measure: Geometric mean titer (GMT) of neutralizing antibody titers

    Time: Through 48 weeks post vaccination

    Other Outcomes

    Description: Endpoint titer of binding antibody in serum at each timepoint

    Measure: Determine IgG antibody responses after a single dose of vaccine related to treatment arm

    Time: Through 1 year post vaccination

    Description: Survival rate

    Measure: Measure survival rate of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2.

    Time: Through 1 year post vaccination

    Description: Endpoint titer of binding antibody in serum at each timepoint Plaque-reduction neutralizing titer in serum at each timepoint T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint

    Measure: Persistence of immune responses following vaccination with GLS-5310

    Time: Through 1 year post vaccination

    Description: Change from baseline in binding antibody titers Change from baseline in T-cell response of antigen-specific interferon - gamma (IFN-γ) Change from baseline in plaque-reduction neutralizing titer(PRNT) in serum

    Measure: Determine the extent of immune boosting for participants who are seropositive at baseline following vaccination with GLS-5310

    Time: Through 1 year post vaccination

    Description: viral load measurement of blood and major organs

    Measure: Measure viral load in organs, including blood, of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2.

    Time: Through 1 year post vaccination

    Description: pathological examination of organs

    Measure: Perform histologic examination of organs of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2.

    Time: Through 1 year post vaccination
    21 First-in-human, Randomised, Double-blind, Placebo-controlled, Dose-escalation Study in Healthy Young Adults Evaluating the Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Candidate for Prevention of COVID-19

    This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Within each of these dose groups, participants will be assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo (saline), or 1 dose of COVI-VAC and 1 dose of placebo. COVI-VAC or placebo is administered by drops into each nostril. Neither the participants nor the researchers will know whether COVI-VAC or placebo has been received. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 14 days after each dose. Safety laboratory tests, physical exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital signs will be measured. Adverse events and medication use will be recorded. Blood samples and intranasal samples will be collected to assess the immune response from the vaccine.

    NCT04619628
    Conditions
    1. COVID-19
    Interventions
    1. Biological: COVI-VAC
    2. Other: Placebo

    Primary Outcomes

    Description: Percentage of subjects with reactogenicity events

    Measure: Reactogenicity

    Time: 14 days after each dose

    Description: Percentage of subjects with adverse events

    Measure: Adverse events

    Time: Days 1 through 57

    Description: Percentage of subjects with serious adverse events

    Measure: Serious adverse events

    Time: Days 1-400

    Secondary Outcomes

    Description: IgG titre measured by ELISA in serum collected on Days 1, 15, 29, 43, 57, 120, 210, and 400

    Measure: IgG titre

    Time: Days 1, 15, 29, 43, 57, 120, 210, and 400

    Description: Neutralising antibody level measured by microneutralisation assay in serum

    Measure: Neutralizing antibody titre

    Time: Days 1, 15, 29, 43, 57, 120, 210, and 400
    22 Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine in SARS-СoV-2 Infection Prophylactic Treatment

    Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

    NCT04530396
    Conditions
    1. Covid19 Prevention
    Interventions
    1. Biological: Gam-COVID-Vac
    2. Other: placebo

    Primary Outcomes

    Description: Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)

    Measure: percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose

    Time: through the whole study, an average of 180 days

    Secondary Outcomes

    Description: Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19

    Measure: the severity of the clinical course of COVID-19

    Time: through the whole study, an average of 180 days

    Description: Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies

    Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S

    Time: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose

    Description: Describe the strength of cell-mediated immune response induced by the use of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo

    Measure: Changing of antigen-specific cellular immunity level

    Time: the drug administration day before injecting the first dose of the study drug/placebo and 28±2 days after the first dose

    Description: Geometric mean virus-neutralizing antibodies titer

    Measure: Changing of of virus neutralizing antibody titer

    Time: the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose

    Description: Incidence of adverse events in trial subjects compared to placebo

    Measure: Incidence of adverse events in trial subjects

    Time: through the whole study, an average of 180 days

    Description: Severity of adverse events in trial subjects compared to placebo

    Measure: Severity of adverse events in trial subjects

    Time: through the whole study, an average of 180 days

    Description: Percentage of study subjects with antibodies to the N-protein of the SARS - CoV-2 virus that appeared after vaccination

    Measure: estimation of the proportion of study subjects with antibodies to the N-protein of the virus SARS-CoV-2

    Time: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
    23 An Open Study of the Safety, Tolerability and Immunogenicity of the "Gam-COVID-Vac"Vaccine Against COVID-19 (Solution for Intramuscular Injection) With the Participation of Volunteers in the Age Group Over 60 Years

    The purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age

    NCT04587219
    Conditions
    1. Coronavirus Infection
    Interventions
    1. Biological: Gam-COVID-Vac
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values

    Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days

    Time: at days 0, 21, 28, 42

    Description: Determination of Number of Participants With Adverse Events

    Measure: Number of Participants With Adverse Events

    Time: through the whole study, an average of 180 days

    Secondary Outcomes

    Description: Determination of virus neutralizing antibody titer

    Measure: Changing of of virus neutralizing antibody titer

    Time: at days 0, 28, 42

    Description: Determination of antigen-specific cellular immunity

    Measure: Changing of antigen-specific cellular immunity level

    Time: Time Frame: at days 0,28
    24 Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

    This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. One hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.

    NCT04283461
    Conditions
    1. COVID-19
    2. COVID-19 Immunisation
    Interventions
    1. Biological: mRNA-1273

    Primary Outcomes

    Measure: Frequency of solicited local reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Frequency of any medically-attended adverse events (MAAEs)

    Time: Day 1 to Day 394

    Measure: Frequency of any new-onset chronic medical conditions (NOCMCs)

    Time: Day 1 to Day 394

    Measure: Frequency of any serious adverse events (SAEs)

    Time: Day 1 to Day 394

    Measure: Frequency of any unsolicited adverse events (AEs)

    Time: Through 28 days post-vaccination

    Measure: Frequency of solicited systemic reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Grade of any unsolicited adverse events (AEs)

    Time: Through 28 days post-vaccination

    Measure: Grade of solicited local reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Grade of solicited systemic reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Secondary Outcomes

    Measure: Geometric mean fold rise (GMFR) in IgG titer from baseline

    Time: Day 1 to Day 57

    Measure: Geometric mean titer (GMT) of antibody

    Time: Day 57

    Description: Seroconversion is defined as a 4-fold change in antibody titer from baseline

    Measure: Percentage of subjects who seroconverted

    Time: Day 1 to Day 57
    25 A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

    This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS CoV 2 RNA vaccine candidates against COVID 19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose). Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.

    NCT04368728
    Conditions
    1. SARS-CoV-2 Infection
    2. COVID-19
    Interventions
    1. Biological: BNT162b1
    2. Biological: BNT162b2
    3. Other: Placebo

    Primary Outcomes

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: Percentage of participants in Phase 1 reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: Percentage of participants in Phase 1 reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 1 reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 1 reporting serious adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 1 day after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 7 days after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 7 days after dose 2

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

    Time: Between baseline and 1 day after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

    Time: Between baseline and 7 days after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

    Time: Between before dose 2 and 7 days after dose 2

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Description: As elicited by investigational site staff

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 2/3 reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 2/3 reporting serious adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: As elicited by investigational site staff

    Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Secondary Outcomes

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels

    Time: Through 2 years after the final dose

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: As measured at the central laboratory

    Measure: GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age)

    Time: 1 month after the second dose
    26 A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults

    This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.

    NCT04463472
    Conditions
    1. COVID-19
    Interventions
    1. Biological: AG0301-COVID19
    2. Biological: AG0301-COVID19

    Primary Outcomes

    Description: Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after each vaccination

    Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time: Week 1 through Week 9

    Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

    Measure: Immunogenicity

    Time: Weeks 3, 5, 7, 9

    Secondary Outcomes

    Measure: Change in GMT of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

    Time: Weeks 13, 25, 53

    Measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody

    Time: Weeks 3, 5, 7, 9, 13, 25, 53

    Measure: Change in GMT of anti-SARS-CoV-2 B cell epitope antibody

    Time: Weeks 3, 5, 7, 9, 13, 25, 53

    Measure: Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

    Time: Weeks 3, 5, 7, 9, 13, 25, 53

    Measure: Adverse events

    Time: Week 9 through Week 53
    27 A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older

    The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.

    NCT04470427
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: mRNA-1273
    2. Biological: Placebo

    Primary Outcomes

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Measure: Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal

    Time: Up to Day 759 (2 years after second dose)

    Measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

    Time: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose)

    Measure: Number of Participants with Unsolicited AEs

    Time: Up to Day 57 (28 days after each dose)

    Secondary Outcomes

    Description: Clinical signs indicative of severe COVID-19 as predefined for the study.

    Measure: Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of mRNA-1273

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 Infection as predefined for the study.

    Measure: Number of Participants with a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection regardless of symptomatology or Severity Starting 14 Days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)]

    Description: Clinical signs indicative of secondary case definition of COVID-19 as predefined for the study.

    Measure: Number of Participants with a Secondary Case Definition of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 as predefined for the study.

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of mRNA-1273 or Placebo

    Time: Day 1 (first dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo regardless of evidence of prior SARS-CoV-2 Infection

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.

    Measure: Number of Participants with a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

    Measure: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

    Measure: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

    Measure: Quantified Levels or GMT of S Protein-Specific Binding Antibody (bAb)

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

    Measure: GMFR of S Protein Specific bAb

    Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759
    28 A Phase 2/3, Randomized, Observer-Blind, Placebo Controlled Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS CoV 2 Vaccine in Healthy Adolescents 12 to <18 Years of Age

    The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety and reactogenicity of a single dose level of mRNA-1273 vaccine administered in 2 doses 28 days apart to an adolescent population.

    NCT04649151
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: mRNA-1273
    2. Biological: Placebo

    Primary Outcomes

    Measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

    Time: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose)

    Measure: Number of Participants with Unsolicited Adverse Events (AEs)

    Time: Up to Day 57 (28 days after each dose)

    Measure: Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI)

    Time: Up to Day 394 (1 year after second dose)

    Description: Acceptable serum Ab threshold as predefined for the study.

    Measure: Number of Participants Who have Reached the Acceptable Threshold for the Serum Ab Level at Day 57

    Time: Day 57 (28 days after second dose)

    Measure: Comparison of the Geometric Mean of the Serum Neutralizing Antibody (nAb) level against the Geometric Mean of the Serum nAb level in Study mRNA-1273-P301 (NCT04470427)

    Time: Day 57 (28 days after second dose)

    Secondary Outcomes

    Measure: Geometric Mean Value of SARS-CoV-2 Spike Protein (S2P)-specific binding antibody (bAb)

    Time: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2)

    Measure: Geometric Mean Value of SARS-CoV-2-specific nAb

    Time: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2)

    Description: Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.

    Measure: Number of Participants with a SARS-CoV-2 Infection Starting on Day 57

    Time: Day 57 up to Day 394

    Description: Clinical signs indicative of COVID-19 as predefined for the study.

    Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

    Time: Day 29 (second dose) up to Day 394 (1 year after second dose)
    29 Novel Use of an Existing Vaccine (BCG) Alliance: The NUEVA Trial

    The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed. Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection. This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers. A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.

    NCT04632537
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine
    2. Drug: Preservative-free saline

    Primary Outcomes

    Description: The primary outcome measure is the development of symptomatic COVID 19 infections. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of rt-PCR-confirmed symptomatic SARS-CoV-2 infection following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.

    Measure: Incidence of symptomatic rt-PCR-confirmed SARS-CoV-2 infection

    Time: 6 months

    Secondary Outcomes

    Description: The secondary outcome measure is the development of Serology-confirmed infection with SARS-CoV-2. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of serology-confirmed SARS-CoV-2 following BCG vaccination compared to that following placebo, starting from 3 days post vaccination through 6 months.

    Measure: incidence of Serology-confirmed infection with SARS-CoV-2

    Time: 6 months

    Description: In individuals who test positive for COVID-19, the proportion with severe disease following BCG vaccination compared to placebo, as defined by the following necessary care levels: non- hospital care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died.Additional WHO severity indicators of severe pneumonia, respiratory failure, sepsis, septic shock will also be included.

    Measure: severity of COVID-19 disease

    Time: 6 months

    Description: Incidence of self-reported symptomatic respiratory infections following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.

    Measure: symptomatic respiratory infection

    Time: 6 months

    Description: rates of 1) all cause respiratory infection 2) symptomatic COVID- 19, 3) serology-confirmed SARS-CoV-2 infection in health care workers.

    Measure: effect of prior adult immunization with other vaccines associated with trained immunity

    Time: 6 months
    30 A Randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Twice or Three Times Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults

    This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult volunteers.

    NCT04527081
    Conditions
    1. COVID-19
    Interventions
    1. Biological: AG0302-COVID19
    2. Biological: AG0302-COVID19
    3. Biological: AG0302-COVID19

    Primary Outcomes

    Description: Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after each vaccination

    Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time: Week 1 through Week 9

    Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody

    Measure: Immunogenicity

    Time: Weeks 3, 5, 7, 9

    Secondary Outcomes

    Measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody

    Time: Weeks 13, 25, 53

    Measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody

    Time: Weeks 3, 5, 7, 9, 13, 25, 53

    Measure: Change in GMT of anti-SARS-CoV-2 B cell epitope antibody

    Time: Week 9

    Measure: Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

    Time: Weeks 3, 5, 7, 9, 13, 25, 53

    Measure: Change in the neutralizing activity against pseudovirus of SARS-CoV-2

    Time: Weeks 3, 5, 7, 9, 13, 25, 53

    Measure: Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2

    Time: Weeks 3, 5, 7, 9, 13, 25, 53

    Measure: Change in IFN-γ production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells

    Time: Weeks 3, 5, 7, 9, 13, 25, 53

    Measure: Adverse events

    Time: Week 9 through Week 53
    31 A Randomized, Double-blind, Placebo Controlled Phase II / III Study to Assess Safety, Immunogenicity and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults

    This study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.

    NCT04655625
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Group A (AG0302-COVID19)
    2. Biological: Group A (Placebo)
    3. Biological: Group B (AG0302-COVID19)
    4. Biological: Group B (Placebo)

    Primary Outcomes

    Description: Frequency and severity of each adverse event solicited local and systemic AEs from the first vaccination to 4 weeks after the second vaccination

    Measure: Incidence of Treatment-Emergent Adverse Events

    Time: Group A: 6 weeks Group B: 8 weeks

    Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody

    Measure: Immunogenicity

    Time: Group A: Week 7 Group B: Week 9

    Secondary Outcomes

    Measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody

    Time: Group A: Weeks 5, 25, 53 Group B: Weeks 7, 25, 53

    Measure: Change in the neutralizing activity against pseudovirus of SARS-CoV-2

    Time: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53

    Measure: Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells

    Time: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53

    Measure: IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody

    Time: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53

    Measure: Adverse events

    Time: Group A: Week 7 through Week 53 Group B: Week 9 through Week 53

    Measure: Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination

    Time: Week 1 through Week 53
    32 Randomized Controlled Trial Evaluating the Efficacy of Vaccination With Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 Via the Strengthening of Innate Immunity in Health Care Workers

    Healthcare Workers (HCW) are at high risk for COVID-19. In addition to the risk of serious forms among HCW, significant absenteeism due to illness would have dramatic consequences in our ability to fight COVID-19. No coronavirus vaccine is available today and drug treatments are only at the start of clinical evaluation. Available since 1921, the bacillus Calmette and Guérin (BCG) is the most widely used vaccine in the world (> 3 billion doses administered) with an extremely low rate of adverse effects. BCG is indicated for the prevention of tuberculosis (TB), but more recent studies have shown that it also has nonspecific immune properties which may be interesting in the current COVID-19 epidemic. Data in mice and in humans have demonstrated protection conferred by BCG against viral respiratory infections such as influenza. In countries with high endemic TB, BCG decreases the incidence of acute respiratory infections by up to 80%, neonatal BCG vaccination has been shown to greatly reduce the risk of sepsis and of hospitalization of children for reasons other than TB. A recent study conducted in South Africa showed that re-vaccination with BCG in adults reduced the incidence of respiratory infections by 70% compared to unvaccinated controls. Beyond respiratory infections, BCG has also shown protective effects against inflammatory diseases. These non-specific beneficial effects are likely linked to the induction of "trained innate immunity", implying epigenetic and metabolic re-programming of innate immune cells. It is therefore possible that revaccination with BCG could significantly reduce the incidence and severity of COVID-19. Very recent ecological observations indeed suggest an inverse correlation between BCG vaccination coverage and the morbidity and mortality of COVID-19. In this context several trials began in Europe and Australia to evaluate the efficacy of BCG vaccination in populations at risk of exposure (HCW) or severe disease (elderly). This study is aligned with studies carried out in Australia, The Netherlands and Spain. In contrast to these latter studies, virtually all French study participants have been vaccinated in their childhood, since BCG vaccination was mandatory in France in neonates until 2007, and in HCW until recently. Therefore, the French study will be in a unique situation to evaluate the effect of re-vaccination with BCG in the context of BCG priming decades before revaccination.

    NCT04384549
    Conditions
    1. Infection
    2. Viral, Agent as Cause of Disease Classified Elsewhere
    Interventions
    1. Biological: BCG GROUP
    2. Other: PLACEBO GROUP

    Primary Outcomes

    Description: Documented COVID-19, i.e. symptomatic COVID-19 confirmed by either positive nasopharyngeal tests for SARS CoV2 and/or by thoracic tomodensitometry compatible with the diagnosis. and/or SARS CoV2 seroconversion

    Measure: Incidence of documented COVID-19 among health care workers exposed to SARS CoV2 and vaccinated with BCG compared to placebo.

    Time: during the study period of 6 months

    Secondary Outcomes

    Description: Participants having developed a severe form of COVID-19, as defined by the necessity for hospitalization in ICU and O2 or artificial ventilation, or extracorporeal membrane oxygenation, or death

    Measure: Numbers of COVID-19 patients requiring hospitalization in ICU and O2, artificial ventilation or extracorporal membrane oxygenation, or deaths in BCG-vaccinated health care workers compared to placebo

    Time: during the study period of 6 months.

    Description: Participants with seroconversion during the study, without symptoms related to COVID-19

    Measure: Incidence of asymptomatic SARS CoV2 seropositive subjects among BCG-vaccinated health care workers compared to placebo.

    Time: during the study period of 6 months.

    Description: Participants presenting any kind of respiratory infection due to any cause

    Measure: Incidence of subjects with any respiratory infection among BCG-vaccinated health care workers compared to placebo.

    Time: during the study period of 6 months.

    Description: Numbers of sick days and number of sick leaves

    Measure: Numbers of sick days and numbers of sick leaves among BCG-vaccinated health care workers compared to placebo.

    Time: during the study period of 6 months

    Description: Local and general events following BCG revaccination after BCG revaccination

    Measure: Numbers of subjects with BCG-related advers events among BCG-vaccinated health care workers compared to placebo.

    Time: 30 days after BCG revaccination

    Description: Potentially modified markers of innate immunity upon SARS CoV-2 infection to be identified

    Measure: Numbers and intensity of changes in innate immune markers after SARS CoV2 infection among BCG-vaccinated health care workers compared to placebo.

    Time: during the study period of 6 months.
    33 A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-Human Study of the Safety and Immunogenicity of AdCOVID Administered as One or Two Doses

    A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.

    NCT04679909
    Conditions
    1. Healthy Volunteers
    Interventions
    1. Biological: AdCOVID
    2. Other: Placebo

    Primary Outcomes

    Description: Counts and percentages of subjects with local and systemic events

    Measure: Reactogenicity

    Time: For 7 days after vaccination

    Description: Counts and percentages of subjects with AEs

    Measure: Adverse Events (AEs)

    Time: Day 1 to Day 57

    Secondary Outcomes

    Measure: Anti-SARS-CoV-2 spike IgG antibody levels

    Time: Day 1 to Day 366

    Measure: Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus

    Time: Day 1 to Day 366

    Other Outcomes

    Measure: Anti-SARS-CoV-2 RBD T cell responses by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot)

    Time: Day 1 to Day 366

    Measure: Mucosal antibody responses in nasopharyngeal swabs (anti-SARS-CoV-2 spike IgA titers)

    Time: Day 1 to Day 366
    34 A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older

    The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort, in healthy adults aged greater than or equal to 18 to less than or equal to 55 years and in adults aged greater than or equal to 65 years in good health with or without stable underlying conditions.

    NCT04436276
    Conditions
    1. Healthy
    Interventions
    1. Biological: Ad26.COV2.S
    2. Biological: Placebo

    Primary Outcomes

    Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination

    Time: Day 8 (7 Days after first vaccination on Day 1)

    Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination

    Time: Day 64 (7 Days after second vaccination on Day 57)

    Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination

    Time: Day 8 (7 Days after first vaccination on Day 1)

    Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination

    Time: Day 64 (7 Days after second vaccination on Day 57)

    Description: Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination

    Time: Day 29 (28 Days after first vaccination on Day1)

    Description: Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination

    Time: Day 85 (28 Days after second vaccination)

    Description: SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

    Measure: Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination

    Time: From Day 57 (vaccination 2) up to 1 year

    Description: SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

    Measure: Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination

    Time: Day 1 (vaccination 1) up to 6 Months

    Secondary Outcomes

    Description: Number of participants with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported.

    Measure: Cohorts 1, 2, and 3: Number of Participants With SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA)

    Time: Up to 38 Months

    Description: Number of participants with SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.

    Measure: Cohorts 1, 2, and 3: Number of Participants with SARS-CoV-2 Binding Antibodies Assessed by ELISA

    Time: Up to 38 Months

    Description: Number of participants with Th-1 and Th-2 immune responses will be reported. Th1 and Th2 immune responses will be assessed by flow cytometry after SARS-CoV-2 S protein peptide stimulation of peripheral blood mononuclear cells (PBMCs) and intracellular staining [ICS] including cluster of differentiation (CD)-4+/CD-8+, Interferons (INF)-gamma, interleukin [IL] 2, Tumor Necrosis Factor (TNF)-alpha, IL-4, IL-5, IL-13, and/or other Th-1/Th-2 markers.

    Measure: Cohorts 1, 2, and 3: Number of Participants with T-helper (Th)-1 and Th-2 Immune Responses as Assessed by Flow Cytometry

    Time: Up to 38 Months
    35 A Phase III, Double-blind, Randomized, Placebo-controlled Multicentre Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Healthcare Professionals' Absenteeism in the SARS-CoV-2 Pandemic by Modulating the Immune System

    The aim of this study is to investigate whether vaccination of healthcare professionals with VPM1002 could reduce the number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection). VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine. VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the new corona virus "SARS-CoV 2". A total of 1200 health care professionals (doctors, nurses and paramedical staff) with high expected exposure to SARSCoV-2 infected patients will receive a single dose of either VPM1002 or Placebo. All subjects will be requested to enter data regarding absenteeism, adverse events / serious adverse events, hospitalizations, intensive care unit admissions into an online questionnaire.

    NCT04387409
    Conditions
    1. Infection, Respiratory Tract
    Interventions
    1. Biological: VPM1002
    2. Biological: Placebo
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Measure: Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection)

    Time: From day 0 to day 240

    Secondary Outcomes

    Measure: Cumulative incidence of documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days absent from work due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days absent from work due to exposure to person with documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days absent from work due to symptoms of respiratory disease, documented SARS-CoV-2 infection, or fever (≥ 38 °C)

    Time: From day 0 to day 240

    Measure: Number of days of self-reported fever (≥ 38 °C)

    Time: From day 0 to day 240

    Measure: Number of days of self-reported acute respiratory symptoms

    Time: From day 0 to day 240

    Measure: Cumulative incidence of self-reported acute respiratory symptoms

    Time: From day 0 to day 240

    Measure: Cumulative incidence of death for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of death due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Cumulative incidence of ICU admission for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Cumulative incidence of hospital admission for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240
    36 Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure

    This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 disease in participants at high risk of exposure to SARS-CoV-2. The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 6178 participants.

    NCT04642638
    Conditions
    1. Coronavirus Infection
    2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
    3. COVID-19 Disease
    Interventions
    1. Drug: INO-4800
    2. Device: CELLECTRA® 2000
    3. Drug: Placebo
    4. Device: CELLECTRA® 2000
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay

    Time: Baseline up to Day 393

    Measure: Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay

    Time: Baseline up to Day 393

    Measure: Phase 3: Percentage of Participants With Virologically-confirmed COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Secondary Outcomes

    Measure: Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Injection Site Reactions

    Time: From time of consent up to 28 days post-dose 2 (up to Day 56)

    Measure: Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Systemic Adverse Events (AEs)

    Time: From time of consent up to 28 days post-dose 2 (up to Day 56)

    Measure: Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs)

    Time: Baseline up to Day 393

    Measure: Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs)

    Time: Baseline up to Day 393

    Measure: Phase 3: Percentage of Participants With Death From All Causes

    Time: Baseline up to Day 393

    Measure: Phase 3: Percentage of Participants With Non-Severe COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Percentage of Participants With Severe COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Percentage of Participants With Death From COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infections

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Days to Symptom Resolution in Participants With COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay

    Time: Baseline up to Day 393

    Measure: Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay

    Time: Baseline up to Day 393
    37 Pilot Study to Evaluate Safety and Efficacy of Anti-SARS-CoV-2 Equine Immunoglobulin F(ab')2 Fragments (INOSARS) in Hospitalized Patients With COVID-19

    This is a two-center, randomized, placebo-controlled pilot study of anti-SARS-CoV-2 equine immunoglobulin fragments F(ab')2 (INOSARS) to evaluate safety and preliminary efficacy in the treatment of hospitalized COVID-19 patients. Clinical improvement at 28 days from the start of treatment will be evaluated.

    NCT04514302
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Placebo
    2. Drug: Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS)

    Primary Outcomes

    Description: The primary endpoint is the proportion of patients with clinical improvement at 28 days after treatment. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale. Scale categories as follows: 1 = not hospitalized; 2 = not hospitalized with limitation of activities and/or oxygen requirement; 3 = hospitalized not requiring supplemental oxygen and not requiring active medical care, 4 = hospitalized requiring active medical care without requiring oxygen supplementation; 5 = hospitalized requiring oxygen supplementation; 6 = hospitalized requiring high-flow oxygen or non-invasive mechanical ventilation; 7 = hospitalized requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8 = death.

    Measure: Proportion of patients with improvement in clinical status

    Time: 28 days

    Secondary Outcomes

    Description: Time from the day of treatment until the first day with clinical improvement, defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale.

    Measure: Time to clinical improvement

    Time: 28 days

    Description: Proportion of participant death or non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation requirement.

    Measure: Proportion of patients that reach a score of 6, 7 or 8 in the NIAID 8-point ordinal scale

    Time: 28 days

    Description: Measured in days

    Measure: Duration of hospitalization

    Time: 28 days

    Description: Proportion of patients that have a negative polymerase chain reaction assay for SARS-CoV-2 at 72 hrs from start of treatment.

    Measure: SARS-CoV-2 PCR negativization rate

    Time: 3 days

    Description: Proportion of patients with clinical improvement at day 7. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale

    Measure: Proportion of patients with clinical improvement at day 7

    Time: 7 days

    Description: Proportion of patients that present within 24 hours of treatment with immediate adverse events defined as: skin rash and/or respiratory findings (dyspnea, wheezing, bronchospasm, hypoxia) and/or circulatory compromise (reduction of blood pressure or associated symptoms, i.e. syncope).

    Measure: Proportion of patients with immediate adverse events (< 24 hours)

    Time: 24 hours

    Description: Proportion of patients that present events associated with serum sickness (type 3 hypersensitivity), vasculitis, glomerulonephritis, arthritis.

    Measure: Proportion of patients with late adverse events (1 - 28 days)

    Time: 28 days
    38 Safety and Efficacy of ALLOSTIM® Universal Anti-Viral Immunodulatory Vaccine for Healthy Elderly Adults

    This protocol tests the safety and efficacy of a novel universal vaccine concept called "allo-priming" which is designed to protect elderly adults from progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses.

    NCT04441047
    Conditions
    1. Virus Diseases
    Interventions
    1. Drug: AlloStim
    MeSH:Virus Diseases

    Primary Outcomes

    Description: vaccine events such as fever, rash, abnormal vital signs

    Measure: frequency of vaccine events

    Time: day 0 to day 28

    Description: measurement of Th1/Th2 balance, allo-specific Th1/CTL response

    Measure: Proportion of subjects with positive T-cell response

    Time: day 0 to 1 year

    Description: ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B

    Measure: Proportion of subjects able to suppress viral propagation

    Time: day 0 to 1 year
    39 CSP #2030 - Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19

    The purpose of this study is to identify early signals of efficacy or harm associated with convalescent plasma therapy in a population of Veteran inpatients with coronavirus disease 2019 (COVID-19).

    NCT04545047
    Conditions
    1. Novel Coronavirus Disease 2019 (COVID-19)
    Interventions
    1. Biological: COVID-19 convalescent plasma
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: Death at any time after admission recorded in the electronic health record. Specific estimates of risk of death will be produced for 7 days, 14 days, 21 days and 28 days, and total deaths.

    Measure: All-cause mortality

    Time: up to 28 days

    Secondary Outcomes

    Description: Number of days from index date to first intubation in non-mechanically ventilated patients

    Measure: Time to first intubation

    Time: 28 days

    Description: Number of days from index date to hospital discharge

    Measure: Time to hospital discharge

    Time: 28 days

    Description: Number of days from index date to death from any cause

    Measure: Time to all-cause mortality

    Time: 28 days

    Description: Long-term outcomes will include death at one year following the index date.

    Measure: All-cause mortality

    Time: 1 year

    Related HPO nodes (Using clinical trials)


    HP:0011947: Respiratory tract infection
    Genes 816
    KMT2D SMARCB1 ABCA12 TNFSF11 TRAIP MAGEL2 DNAAF1 NFE2L2 NFKB2 LCK MAGEL2 SGCG TECPR2 GTF2IRD1 CHAMP1 OFD1 SCNN1G CD247 MGP SPINK5 CTPS1 NTRK1 NGLY1 RELB ZNF341 RSPH9 FCN3 NELFA MALT1 CFTR OCA2 LETM1 PIK3CD FMO3 USP9X HLA-DPA1 DNAH11 ZAP70 UNC119 WAS SIM1 GNPTAB FOXH1 CFAP221 TARS1 LAMB2 MYO5A CD81 ADNP TNFRSF13B MYH6 TSC1 CYBA HLA-DPB1 GNS FOXH1 LIPN KATNIP TPM2 COL6A1 NIPBL SPAG1 IL17RA GAS1 SLC12A6 EFEMP2 CRLF1 GMNN CTLA4 SLC35A1 ADAMTS3 TAPBP SLC25A24 CXCR4 BLM RNU4ATAC CFAP300 FOXP1 CDON CD79A RAG1 VPS51 DISP1 USB1 NEPRO COL11A2 CR2 LAMTOR2 SNORD115-1 MAP3K20 DNMT3B MKRN3-AS1 LYST PIK3R1 ACADVL TDGF1 RFX5 VPS33A MDM4 TBC1D24 NGLY1 GLI2 FGF8 ODAD4 CCDC40 MCM4 CRELD1 ZBTB24 TINF2 ECM1 LRRC6 CFTR COL11A2 CR2 ELP1 TFRC AGA SMPD1 PWRN1 IPW TCIRG1 BLNK FLI1 UBB KIF20A STAT1 MBTPS2 ELP1 SNRPN DISP1 RMRP STAG2 IRF8 SIX3 KIF1A RYR1 IGHM BTK CYP4F22 CXCR4 RSPH1 CCBE1 DNAH11 ZIC2 CSF2RA POLR3A LAMA2 STAT1 SNX10 FGF8 FOXJ1 AICDA SHH RYR1 ODAD1 SIK1 HACD1 CREBBP TNFRSF13B CITED2 OCA2 NODAL NOTCH2 CFAP298 SELENON ZIC2 ALMS1 ODAD4 IDUA DLL1 SBDS COG6 TBX6 RFXAP PEX13 TCTN3 PTPN22 SFTPC MAGEL2 COG4 EPM2A MESP2 TTC12 TBC1D23 SCNN1B TGFB1 MAN2B1 PTCH1 NPM1 EPG5 UGP2 GLI2 GAS2L2 TSC2 RANBP2 SCN11A CTLA4 MESP2 IL21R IL17RC UMPS SLC18A3 MYSM1 TRPS1 MKRN3 RPGR DSG1 ACP5 JAK3 EXOSC9 MIR140 DNAL1 NCF4 ACTC1 VAMP1 TGFB1 CD3E IDUA FANCF PLCG2 SLC29A3 NDN RAG2 RAG2 SLC46A1 PGM3 GBA IL2RG SULT2B1 DNAJB13 SDR9C7 MSN MYOD1 FCGR3A SHROOM4 PNP ACTA1 ERF MYSM1 LEPR FLNC NCF4 ODAD2 RFXANK KAT6B DNAI1 NEK10 DNAI1 MPLKIP AGA LAMC2 RAG2 LEPR IL17F DCLRE1C LIMK1 PEPD ITGA3 ZBTB24 NCF1 CD3D EP300 IL2RB GLI2 COL6A3 FBLN5 TASP1 DCLRE1C PYROXD1 IL7R TBC1D24 PLCG2 GAA ODAD3 NFKBIA IL17RA KRAS IGLL1 SCNN1A ODAD3 TK2 TPM3 RNF113A IGHM CCDC39 MS4A1 SMN1 SMARCC2 LEP CYBB NEU1 CD3E PTPRC PLG FOXH1 TNNI3 TYK2 ORC6 RNF168 CARD11 CD3G LONP1 GNPTAB IDUA CYBB NBN NRAS DNAAF6 TGIF1 WAC ADA STAT3 SETBP1 CD3D STAT3 RSPH4A HLA-B TSC1 DNMT3B ITCH GAS1 NEK10 CCDC22 SAMD9 CD247 CFI TREX1 ASAH1 INPPL1 MECP2 HYDIN DNAAF2 IL6R LAMB3 NFKB1 RUNX2 KANSL1 PTCH1 TDGF1 RAG1 UBE2A NFKB2 PIK3CD SMN1 TGIF1 HELLS RSPH9 MTHFD1 SMARCD1 OCRL SLC52A3 DZIP1L TDGF1 WDR1 ALB ADA2 DLL1 SHH SIX3 MYL2 STAG2 EFL1 TERC CFAP410 MASP2 GLB1 LIG4 PARN NFKB2 EDARADD DNAAF6 BCR RNF125 TLL1 DCLRE1C SCNN1A ASAH1 SNAP25 NHP2 DNAAF5 DLL1 EXTL3 PRPS1 MAN2B1 ZMYND10 FOXN1 PRKCD BLNK IL2RG IL7R SMPD1 NODAL NECTIN1 LAMTOR2 RAG2 ROR2 ADA IER3IP1 KDM6A TLL1 ALOXE3 TGIF1 PIGN NOS1 NXN DNAH1 MS4A1 NODAL USB1 LRRC56 ATP6V0A2 EPG5 CASP8 PRPS1 IKBKB ARID2 SHH ARID1B EGFR LAMA3 IKZF1 PLOD1 PRKDC JAK3 DNAAF4 BTK PEPD SCNN1B KCNJ6 GAA MCIDAS SOX4 ZMYND10 UNG GATA6 GATA4 SLC26A2 NDN CD81 NKX2-1 PLOD1 PLEC FGF8 GAS1 ABCA12 IGH CLIP2 SCNN1B CYBC1 RAG1 CLEC7A DRC1 TCIRG1 PMM2 PAFAH1B1 TGM1 DLL1 SIX3 TIMM8A ELN FUCA1 SPAG1 ARID1B ABCA3 ARSB CFB SOX11 FOXP3 USP9X P4HTM AP3B1 POLA1 CDON PKHD1 TAF1 COLQ TCF3 TRIP4 STXBP2 CREBBP NPAP1 STK36 DOCK8 DDR2 CD8A CCDC65 INPPL1 TNFRSF13C KNSTRN SELENON LRRC6 SLC5A7 SHH IFIH1 IL7R CIITA ZIC2 FLNA G6PC3 BACH2 ZNHIT3 DNAJC21 SH2D1A CCNO COL13A1 DISP1 IL21 HYDIN MGP IL2RA MED25 GSN FOXH1 SLC35C1 PNP PRTN3 SP110 ARID1A NBN MCIDAS RAG1 TAP1 SNRPN NADK2 ZAP70 MAGT1 FGFR1 GATA2 ALOX12B IFNGR1 NFKB1 DOCK8 AP3D1 STING1 B2M SRP54 TNFRSF13C TTC12 TAP2 KPTN SNRPN DNAI2 CHRM3 CCNO RAC1 ADA TBX20 ODAD2 BCL10 FLNA SLC25A22 RAG2 GATA4 DNAH9 SMARCA4 TNFRSF11A IRAK4 GUSB CD40LG SCNN1G GUSB KIAA0586 NSD2 DPF2 GBA NCF2 GAS2L2 MYH3 TBCD PTPN22 RAC2 PTCH1 DNAI2 TPP2 RAG1 KANSL1 PURA LRRC56 DNAAF1 SCNN1G IL6ST ACP5 XIAP IL2RG IGLL1 AFF4 SCNN1B BTK PCNT CDON COG4 PRKCD LRRC8A PSAP HLA-DQA1 DYNC2I2 SLC35C1 PWAR1 SLC1A4 CR2 TBCE AGRN CTCF FBLN5 TRIP11 NKX2-5 TSC2 GFI1 TNFSF12 GAS8 MAPK1 DNAAF2 SCNN1A ACTA1 NDN IDS PANK2 FGFR1 CHD7 DNAAF3 DNAAF3 DPM2 OCA2 PCGF2 SFTPB MANBA TNNT2 SRP54 CD79B CD19 FOXJ1 LEP NHLRC1 GATA6 SCNN1A SERPINA1 ATM DNAJB13 CLCN7 CACNA1C SPEF2 CREBBP TNFSF12 COL6A2 RAC2 TBL2 CFTR CFAP298 RSPH3 SDCCAG8 DNAH5 WIPF1 NCF2 FOXP1 RFC2 SNORD116-1 POLR2A CCDC103 OFD1 DNAAF5 PDHA1 CD19 SIX3 LTBP3 SMARCD2 CSF2RB PSMB8 CRKL EP300 RSPH1 ATM DCTN4 CLCA4 CTSC STAT3 FCGR2A DNAH5 CDON TRAF3IP2 IDS CD79A PIK3R1 GRHL3 NOP10 HPS6 RPGR SCNN1G CD79B IVNS1ABP ZIC2 AFF4 ITGA7 ERCC2 RAB3GAP2 RTEL1 CYBA SCN9A RASGRP1 FGF8 SNRPN CARD11 POLE ICOS NME8 HLA-DQB1 PGM3 CDCA7 SAMD9L SMC1A ICOS GLI3 SREBF1 CHAT RFX5 TDGF1 CCDC40 SMARCE1 DCLRE1C ALMS1 NCF1 RSPH3 CYBC1 SLC25A1 PTCH1 IL2RG GLI2 GAS1 TNFRSF13B WAS EHMT1 WRAP53 TGIF1 GLUL SH3KBP1 RFXAP CARMIL2 GTF2I TNFRSF1A MAGEL2 HGSNAT MYO9A GTF2H5 TERT RYR1 FAT4 RIPK1 COL13A1 JAGN1 CIITA TBX20 CSPP1 DNAAF4 HK1 NFIX RNU4ATAC BIRC3 IKBKB CD27 NDN TGFB1 PIK3R1 CREBBP ALPL CCDC103 NAGLU ODAD1 CTC1 SNRPN PRPS1 DLL3 LYST GBA NME8 MYPN STX1A TNFRSF13C HERC2 ELANE CORO1A SYT2 CCDC39 CFTR ICOS RFXANK EP300 MAGEL2 WDR19 ALG12 AK2 CD55 GAS8 DKC1 NKX2-1 SCN10A NODAL LRBA ELANE GTF2E2 SGSH BAZ1B PLP1 CACNA1B RSPH4A CCDC65 MID1 NR2F2 ERCC3 WASHC5 NIPAL4 VPS33A CD19 GALNS OSTM1 XIAP ASAH1 DISP1
    Protein Mutations 1
    H275Y
    SNP 0

    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    Related HPO nodes (Using clinical trials)


    HP:0011947: Respiratory tract infection
    Genes 816
    KMT2D SMARCB1 ABCA12 TNFSF11 TRAIP MAGEL2 DNAAF1 NFE2L2 NFKB2 LCK MAGEL2 SGCG TECPR2 GTF2IRD1 CHAMP1 OFD1 SCNN1G CD247 MGP SPINK5 CTPS1 NTRK1 NGLY1 RELB ZNF341 RSPH9 FCN3 NELFA MALT1 CFTR OCA2 LETM1 PIK3CD FMO3 USP9X HLA-DPA1 DNAH11 ZAP70 UNC119 WAS SIM1 GNPTAB FOXH1 CFAP221 TARS1 LAMB2 MYO5A CD81 ADNP TNFRSF13B MYH6 TSC1 CYBA HLA-DPB1 GNS FOXH1 LIPN KATNIP TPM2 COL6A1 NIPBL SPAG1 IL17RA GAS1 SLC12A6 EFEMP2 CRLF1 GMNN CTLA4 SLC35A1 ADAMTS3 TAPBP SLC25A24 CXCR4 BLM RNU4ATAC CFAP300 FOXP1 CDON CD79A RAG1 VPS51 DISP1 USB1 NEPRO COL11A2 CR2 LAMTOR2 SNORD115-1 MAP3K20 DNMT3B MKRN3-AS1 LYST PIK3R1 ACADVL TDGF1 RFX5 VPS33A MDM4 TBC1D24 NGLY1 GLI2 FGF8 ODAD4 CCDC40 MCM4 CRELD1 ZBTB24 TINF2 ECM1 LRRC6 CFTR COL11A2 CR2 ELP1 TFRC AGA SMPD1 PWRN1 IPW TCIRG1 BLNK FLI1 UBB KIF20A STAT1 MBTPS2 ELP1 SNRPN DISP1 RMRP STAG2 IRF8 SIX3 KIF1A RYR1 IGHM BTK CYP4F22 CXCR4 RSPH1 CCBE1 DNAH11 ZIC2 CSF2RA POLR3A LAMA2 STAT1 SNX10 FGF8 FOXJ1 AICDA SHH RYR1 ODAD1 SIK1 HACD1 CREBBP TNFRSF13B CITED2 OCA2 NODAL NOTCH2 CFAP298 SELENON ZIC2 ALMS1 ODAD4 IDUA DLL1 SBDS COG6 TBX6 RFXAP PEX13 TCTN3 PTPN22 SFTPC MAGEL2 COG4 EPM2A MESP2 TTC12 TBC1D23 SCNN1B TGFB1 MAN2B1 PTCH1 NPM1 EPG5 UGP2 GLI2 GAS2L2 TSC2 RANBP2 SCN11A CTLA4 MESP2 IL21R IL17RC UMPS SLC18A3 MYSM1 TRPS1 MKRN3 RPGR DSG1 ACP5 JAK3 EXOSC9 MIR140 DNAL1 NCF4 ACTC1 VAMP1 TGFB1 CD3E IDUA FANCF PLCG2 SLC29A3 NDN RAG2 RAG2 SLC46A1 PGM3 GBA IL2RG SULT2B1 DNAJB13 SDR9C7 MSN MYOD1 FCGR3A SHROOM4 PNP ACTA1 ERF MYSM1 LEPR FLNC NCF4 ODAD2 RFXANK KAT6B DNAI1 NEK10 DNAI1 MPLKIP AGA LAMC2 RAG2 LEPR IL17F DCLRE1C LIMK1 PEPD ITGA3 ZBTB24 NCF1 CD3D EP300 IL2RB GLI2 COL6A3 FBLN5 TASP1 DCLRE1C PYROXD1 IL7R TBC1D24 PLCG2 GAA ODAD3 NFKBIA IL17RA KRAS IGLL1 SCNN1A ODAD3 TK2 TPM3 RNF113A IGHM CCDC39 MS4A1 SMN1 SMARCC2 LEP CYBB NEU1 CD3E PTPRC PLG FOXH1 TNNI3 TYK2 ORC6 RNF168 CARD11 CD3G LONP1 GNPTAB IDUA CYBB NBN NRAS DNAAF6 TGIF1 WAC ADA STAT3 SETBP1 CD3D STAT3 RSPH4A HLA-B TSC1 DNMT3B ITCH GAS1 NEK10 CCDC22 SAMD9 CD247 CFI TREX1 ASAH1 INPPL1 MECP2 HYDIN DNAAF2 IL6R LAMB3 NFKB1 RUNX2 KANSL1 PTCH1 TDGF1 RAG1 UBE2A NFKB2 PIK3CD SMN1 TGIF1 HELLS RSPH9 MTHFD1 SMARCD1 OCRL SLC52A3 DZIP1L TDGF1 WDR1 ALB ADA2 DLL1 SHH SIX3 MYL2 STAG2 EFL1 TERC CFAP410 MASP2 GLB1 LIG4 PARN NFKB2 EDARADD DNAAF6 BCR RNF125 TLL1 DCLRE1C SCNN1A ASAH1 SNAP25 NHP2 DNAAF5 DLL1 EXTL3 PRPS1 MAN2B1 ZMYND10 FOXN1 PRKCD BLNK IL2RG IL7R SMPD1 NODAL NECTIN1 LAMTOR2 RAG2 ROR2 ADA IER3IP1 KDM6A TLL1 ALOXE3 TGIF1 PIGN NOS1 NXN DNAH1 MS4A1 NODAL USB1 LRRC56 ATP6V0A2 EPG5 CASP8 PRPS1 IKBKB ARID2 SHH ARID1B EGFR LAMA3 IKZF1 PLOD1 PRKDC JAK3 DNAAF4 BTK PEPD SCNN1B KCNJ6 GAA MCIDAS SOX4 ZMYND10 UNG GATA6 GATA4 SLC26A2 NDN CD81 NKX2-1 PLOD1 PLEC FGF8 GAS1 ABCA12 IGH CLIP2 SCNN1B CYBC1 RAG1 CLEC7A DRC1 TCIRG1 PMM2 PAFAH1B1 TGM1 DLL1 SIX3 TIMM8A ELN FUCA1 SPAG1 ARID1B ABCA3 ARSB CFB SOX11 FOXP3 USP9X P4HTM AP3B1 POLA1 CDON PKHD1 TAF1 COLQ TCF3 TRIP4 STXBP2 CREBBP NPAP1 STK36 DOCK8 DDR2 CD8A CCDC65 INPPL1 TNFRSF13C KNSTRN SELENON LRRC6 SLC5A7 SHH IFIH1 IL7R CIITA ZIC2 FLNA G6PC3 BACH2 ZNHIT3 DNAJC21 SH2D1A CCNO COL13A1 DISP1 IL21 HYDIN MGP IL2RA MED25 GSN FOXH1 SLC35C1 PNP PRTN3 SP110 ARID1A NBN MCIDAS RAG1 TAP1 SNRPN NADK2 ZAP70 MAGT1 FGFR1 GATA2 ALOX12B IFNGR1 NFKB1 DOCK8 AP3D1 STING1 B2M SRP54 TNFRSF13C TTC12 TAP2 KPTN SNRPN DNAI2 CHRM3 CCNO RAC1 ADA TBX20 ODAD2 BCL10 FLNA SLC25A22 RAG2 GATA4 DNAH9 SMARCA4 TNFRSF11A IRAK4 GUSB CD40LG SCNN1G GUSB KIAA0586 NSD2 DPF2 GBA NCF2 GAS2L2 MYH3 TBCD PTPN22 RAC2 PTCH1 DNAI2 TPP2 RAG1 KANSL1 PURA LRRC56 DNAAF1 SCNN1G IL6ST ACP5 XIAP IL2RG IGLL1 AFF4 SCNN1B BTK PCNT CDON COG4 PRKCD LRRC8A PSAP HLA-DQA1 DYNC2I2 SLC35C1 PWAR1 SLC1A4 CR2 TBCE AGRN CTCF FBLN5 TRIP11 NKX2-5 TSC2 GFI1 TNFSF12 GAS8 MAPK1 DNAAF2 SCNN1A ACTA1 NDN IDS PANK2 FGFR1 CHD7 DNAAF3 DNAAF3 DPM2 OCA2 PCGF2 SFTPB MANBA TNNT2 SRP54 CD79B CD19 FOXJ1 LEP NHLRC1 GATA6 SCNN1A SERPINA1 ATM DNAJB13 CLCN7 CACNA1C SPEF2 CREBBP TNFSF12 COL6A2 RAC2 TBL2 CFTR CFAP298 RSPH3 SDCCAG8 DNAH5 WIPF1 NCF2 FOXP1 RFC2 SNORD116-1 POLR2A CCDC103 OFD1 DNAAF5 PDHA1 CD19 SIX3 LTBP3 SMARCD2 CSF2RB PSMB8 CRKL EP300 RSPH1 ATM DCTN4 CLCA4 CTSC STAT3 FCGR2A DNAH5 CDON TRAF3IP2 IDS CD79A PIK3R1 GRHL3 NOP10 HPS6 RPGR SCNN1G CD79B IVNS1ABP ZIC2 AFF4 ITGA7 ERCC2 RAB3GAP2 RTEL1 CYBA SCN9A RASGRP1 FGF8 SNRPN CARD11 POLE ICOS NME8 HLA-DQB1 PGM3 CDCA7 SAMD9L SMC1A ICOS GLI3 SREBF1 CHAT RFX5 TDGF1 CCDC40 SMARCE1 DCLRE1C ALMS1 NCF1 RSPH3 CYBC1 SLC25A1 PTCH1 IL2RG GLI2 GAS1 TNFRSF13B WAS EHMT1 WRAP53 TGIF1 GLUL SH3KBP1 RFXAP CARMIL2 GTF2I TNFRSF1A MAGEL2 HGSNAT MYO9A GTF2H5 TERT RYR1 FAT4 RIPK1 COL13A1 JAGN1 CIITA TBX20 CSPP1 DNAAF4 HK1 NFIX RNU4ATAC BIRC3 IKBKB CD27 NDN TGFB1 PIK3R1 CREBBP ALPL CCDC103 NAGLU ODAD1 CTC1 SNRPN PRPS1 DLL3 LYST GBA NME8 MYPN STX1A TNFRSF13C HERC2 ELANE CORO1A SYT2 CCDC39 CFTR ICOS RFXANK EP300 MAGEL2 WDR19 ALG12 AK2 CD55 GAS8 DKC1 NKX2-1 SCN10A NODAL LRBA ELANE GTF2E2 SGSH BAZ1B PLP1 CACNA1B RSPH4A CCDC65 MID1 NR2F2 ERCC3 WASHC5 NIPAL4 VPS33A CD19 GALNS OSTM1 XIAP ASAH1 DISP1
    Protein Mutations 1
    H275Y
    SNP 0

    Reports

    Data processed on January 01, 2021.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

    Drug Reports   MeSH Reports   HPO Reports  

    Interventions

    4,818 reports on interventions/drugs

    MeSH

    706 reports on MeSH terms

    HPO

    306 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

    Google Colab

    Python example via Google Colab Notebook