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    SARS-CoV-2

    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 (90)


    Name (Synonyms) Correlation
    drug2490 Placebo Wiki 0.50
    drug1366 Gam-COVID-Vac Wiki 0.42
    drug3923 mRNA-1273 Wiki 0.28
    Name (Synonyms) Correlation
    drug899 Convalescent plasma Wiki 0.23
    drug2805 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki 0.21
    drug4004 placebo Wiki 0.18
    drug384 BNT162b1 Wiki 0.18
    drug941 Covigenix VAX-001 placebo 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
    drug1367 Gam-COVID-Vac Lyo Wiki 0.16
    drug1437 Heparin Wiki 0.16
    drug385 BNT162b2 Wiki 0.16
    drug454 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki 0.16
    drug383 BNT162a1 Wiki 0.16
    drug581 COVI-VAC Wiki 0.16
    drug457 Biological: mRNA-1273: 50 mcg Wiki 0.16
    drug99 ARCT-021 Dose 3 Wiki 0.16
    drug739 ChAdOx1 nCoV-19 single dose + paracetamol Wiki 0.16
    drug158 Ad5-nCoV Wiki 0.16
    drug1325 Flu shot Wiki 0.16
    drug2936 SARS-CoV-2 vaccine (inactivated) Wiki 0.16
    drug2002 MenACWY single dose + paracetamol Wiki 0.16
    drug386 BNT162b3 Wiki 0.16
    drug3562 V-SARS Wiki 0.16
    drug3802 convalescent plasma 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
    drug2514 Placebo Comparator Wiki 0.16
    drug160 AdCOVID Wiki 0.16
    drug12 0.9% (w/v) saline Wiki 0.16
    drug2312 One COVID-19 vaccine candidate (TMV-083) administration - High dose Wiki 0.16
    drug452 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki 0.16
    drug453 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki 0.16
    drug1921 MMR vaccine Wiki 0.16
    drug2503 Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) Wiki 0.16
    drug387 BNT162c2 Wiki 0.16
    drug3494 Two COVID-19 vaccine candidate (TMV-083) administrations - High dose Wiki 0.16
    drug456 Biological: mRNA-1273: 100 mcg Wiki 0.16
    drug2278 Observation Wiki 0.16
    drug367 BCG vaccine Wiki 0.16
    drug2812 Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) Wiki 0.16
    drug98 ARCT-021 Dose 2 Wiki 0.16
    drug1583 IIBR-100, low dose (prime) Wiki 0.16
    drug102 ARCT-021 Dose Regimen 2 Wiki 0.16
    drug3495 Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose Wiki 0.16
    drug653 COVID19 vaccine Wiki 0.16
    drug1582 IIBR-100 medium dose (prime) Wiki 0.16
    drug1390 Group A (AG0302-COVID19) Wiki 0.16
    drug1581 IIBR-100 low-dose (prime-boost) Wiki 0.16
    drug2574 Placebo; 0.9% saline Wiki 0.16
    drug2001 MenACWY prime & saline placebo boost + paracetamol Wiki 0.16
    drug1585 IL-12 plasmid Wiki 0.16
    drug164 Adenovirus Type-5 Vectored COVID-19 Vaccine Wiki 0.16
    drug2806 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Wiki 0.16
    drug577 CORVax Wiki 0.16
    drug101 ARCT-021 Dose Regimen 1 Wiki 0.16
    drug109 AS03-adjuvanted SCB-2019 vaccine Wiki 0.16
    drug2254 Normal saline 0.9% Wiki 0.16
    drug1937 MVA-SARS-2-S vaccinations (days 0 & 28) Wiki 0.16
    drug1580 IIBR-100 high-dose (prime) Wiki 0.16
    drug100 ARCT-021 Dose 4 Wiki 0.16
    drug928 Covax-19™ Wiki 0.16
    drug159 AdCLD-CoV19 Wiki 0.16
    drug1210 EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki 0.16
    drug2777 RUTI® vaccine Wiki 0.16
    drug940 Covigenix VAX-001 Wiki 0.16
    drug128 AZD1222 Wiki 0.14
    drug2930 SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki 0.11
    drug731 ChAdOx1 nCoV-19 Wiki 0.11
    drug394 Bacille Calmette-Guérin (BCG) Wiki 0.11
    drug4042 rAd26-S Wiki 0.11
    drug2988 Saline Placebo Wiki 0.11
    drug678 CVnCoV Vaccine Wiki 0.11
    drug2529 Placebo Vaccine Wiki 0.11
    drug3523 UB-612 Wiki 0.11
    drug80 AG0301-COVID19 Wiki 0.11
    drug1592 INO-4800 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
    drug366 BCG Vaccine Wiki 0.08
    drug557 CELLECTRA® 2000 Wiki 0.08
    drug2985 Saline Wiki 0.07

    Correlated MeSH Terms (17)


    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.36
    D007239 Infection NIH 0.35
    D045169 Severe Acute Respiratory Syndrome NIH 0.33
    Name (Synonyms) Correlation
    D000257 Adenoviridae Infections NIH 0.29
    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
    D012327 RNA Virus Infections NIH 0.16
    D008173 Lung Diseases, Obstructive NIH 0.16
    D014777 Virus Diseases NIH 0.13
    D018450 Disease Progression NIH 0.11
    D011014 Pneumonia NIH 0.11
    D012141 Respiratory Tract Infections NIH 0.08
    D003141 Communicable Diseases NIH 0.07

    Correlated HPO Terms (5)


    Name (Synonyms) Correlation
    HP:0006510 Chronic pulmonary obstruction HPO 0.16
    HP:0006536 Pulmonary obstruction HPO 0.16
    HP:0100806 Sepsis HPO 0.16
    Name (Synonyms) Correlation
    HP:0002090 Pneumonia HPO 0.11
    HP:0011947 Respiratory tract infection HPO 0.08

    Clinical Trials

    Navigate: Correlations   HPO

    There are 39 clinical trials


    1 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
    2 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
    3 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)
    4 Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above

    This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.

    NCT04510207
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
    2. Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
    3. Biological: Placebo

    Primary Outcomes

    Measure: The incidence of COVID-19 cases after two-doses of vaccination

    Time: From14 days after the second dose to 6 month after the second dose

    Secondary Outcomes

    Measure: The incidence of severe cases of SARS-CoV-2 pneumonia and deaths accompanied by COVID-19 after two-doses of vaccination

    Time: From14 day after the second dose to 6 month after the second dose

    Measure: The incidence of any adverse reactions/events

    Time: 28 days after each immunization

    Measure: The incidence of serious adverse events (SAE)

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

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

    Time: 14 days after full course of immunization

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

    Time: 14 days after full course of immunization

    Measure: The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody

    Time: 14 days after full course of immunization

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

    Time: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization

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

    Time: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization

    Measure: The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody

    Time: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization

    Other Outcomes

    Measure: the anti-SARS-CoV-2 neutralizing antibody protective level against COVID-19

    Time: 14 days after 2 doses of vaccination

    Measure: The occurrence of ADE

    Time: From the beginning of the first dose to 12 months after the second immunization
    5 An Open, Single-center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-SARS-2-S

    In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.

    NCT04569383
    Conditions
    1. Covid19
    Interventions
    1. Biological: MVA-SARS-2-S vaccinations (days 0 & 28)

    Primary Outcomes

    Description: Safety and reactogenicity will be assessed by observation, questionaire and diary. Occurence of Serious Adverse Events (SAE) will be collected throughout the entire study duration.

    Measure: Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol

    Time: during the entire study (up to 6 months)

    Secondary Outcomes

    Description: Magnitude of SARS-CoV2-specific antibody responses (ELISA and neutralization assays) monitored in an approved laboratory

    Measure: Immunogenicity. Number of participants who seroconverted

    Time: during the entire study (up to 6 months)
    6 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
    7 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)
    8 A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia

    This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation

    NCT04508075
    Conditions
    1. SARS-CoV2 Infection
    Interventions
    1. Biological: SARS-CoV-2 vaccine (inactivated)
    2. Biological: Placebo
    MeSH:Infection

    Primary Outcomes

    Description: Percentage of laboratory-confirmed COVID-19 cases

    Measure: Incidence of laboratory-confirmed COVID-19 after the second dose

    Time: 14 days to 6 months after the second dose

    Secondary Outcomes

    Description: Percentage of suspected COVID-19 cases

    Measure: Incidence of suspected COVID-19 cases

    Time: within 14 days to 6 months after the second dose.

    Description: Percentage of laboratory-confirmed cases (severe, critical, death)

    Measure: Incidence of laboratory-confirmed cases (severe, critical and death)

    Time: within 14 days to 6 months after the second dose

    Description: Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches

    Measure: Seroconversion rate anti-S antibody IgG titer (ELISA)

    Time: 14 days after two doses of vaccination

    Description: Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches

    Measure: Seroconversion rate anti-S antibody IgG titer (ELISA)

    Time: 6 months after two doses of vaccination

    Description: Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches

    Measure: Seropositive rate of neutralizing antibodies

    Time: 14 days after two doses of vaccination

    Description: Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches

    Measure: Seropositive rate of neutralizing antibodies

    Time: 6 months after two doses of vaccination

    Other Outcomes

    Description: Number of Local reactions and systemic events

    Measure: Local reaction and systemic events

    Time: 30 minutes to 14 days after each vaccination

    Description: Number of Local reactions and systemic events

    Measure: Local reaction and systemic events occurring after the last vaccination

    Time: 14 days to 28 days following last vaccination

    Description: Number of any SAE occur

    Measure: Serious adverse events during study

    Time: 6 months after the last dose
    9 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
    10 Simple, Blind, Placebo-controlled, Randomized Study of the Safety, Reactogenicity and Immunogenicity of Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), in Volunteers Aged 18-60 Years (I-II Phase)

    The aim of the clinical study is to determine the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years. The research tasks are to: - evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly; - evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly; - identify the development of adverse reactions to vaccine administration; - study the humoral and cellular immune responses following two doses of the EpiVacCorona vaccine.

    NCT04527575
    Conditions
    1. Covid19
    Interventions
    1. Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)
    2. Other: Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)

    Primary Outcomes

    Description: • The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 9 months post vaccination versus a placebo.

    Measure: The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination

    Time: throughout the study, an average of 270 days

    Secondary Outcomes

    Description: • The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA greater ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination compared with a placebo.

    Measure: The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA following the vaccination compared with a placebo.

    Time: at days 0, 1, 14, 20, 35, 42, 90, 180, 270

    Description: • The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.

    Measure: The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo

    Time: at days 0, 1, 14, 20, 35, 42, 90, 180, 270

    Description: • The proportion of volunteers with an ex vivo cellular immune response 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.

    Measure: The proportion of volunteers with an ex vivo cellular immune response following the vaccination, compared with a placebo

    Time: at days 0, 1, 14, 20, 35, 42, 90, 180, 270

    Description: • Immediate adverse events (allergic reactions) that occur within 2 hours after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer; adverse events (local and systemic reactions) that occur within 7 days after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer; other adverse events that occur 7 days after each vaccination (from 8 to 42 days after the first vaccination, excluding the allowable interval of visits) and noted by the volunteer in the Self-observation Diary.

    Measure: Incidence and type of adverse events during the study

    Time: throughout the study, an average of 270 days

    Description: • Incidence of serious adverse events during the study.

    Measure: Incidence of serious adverse events during the study

    Time: throughout the study, an average of 270 days

    Description: • Cases of early termination of participation of volunteers in the study due to the development of adverse events / sever adverse events associated with the use of products under study.

    Measure: Cases of early termination of the study due to the development of adverse events / sever adverse events

    Time: throughout the study, an average of 270 days
    11 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
    12 A Randomized, Placebo-controlled Trial, to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine, a Measles Vector-based Vaccine Candidate Against COVID-19 in Healthy Volunteers Consisting of an Unblinded Dose Escalation and a Blinded Treatment Phase

    This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083).

    NCT04497298
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose
    2. Biological: Two COVID-19 vaccine candidate (TMV-083) administrations - High dose
    3. Biological: One COVID-19 vaccine candidate (TMV-083) administration - High dose
    4. Other: Placebo

    Primary Outcomes

    Description: Rate of solicited Adverse Event up to 14 days after each injection. Rate of unsolicited AE up to 28 days after the last injection. Rate of serious adverse events (SAEs), serious adverse reactions (SARs), suspected unexpected serious adverse reactions (SUSARs) and adverse events of special interest (AESI) all along the study period.

    Measure: To assess the safety and tolerability of the COVID-19 vaccine following one or two consecutive intramuscular injections in healthy volunteers

    Time: Day 390

    Secondary Outcomes

    Description: SARS-CoV-2 specific antibodies up to study day 390 as measured by spike protein-specific ELISA

    Measure: To assess induction of SARS-CoV-2 spike protein-binding antibodies upon one or two administrations of the COVID-19 vaccine by means of ELISA up to study day 390

    Time: Day 390

    Description: SARS-CoV-2 specific antibodies up to study day 390 for each cohort as measured by serum neutralization assay

    Measure: To assess induction of SARS-CoV-2 neutralizing antibodies upon one or two administrations of the COVID-19 vaccine by means of serum neutralization assay up to study day 390

    Time: Day 390

    Description: SARS-CoV-2 spike protein-specific cell-mediated immune response up to study day 390 induced by one or two doses as measured by intracellular staining and flow cytometry

    Measure: To assess SARS-CoV-2 spike protein-specific, cell-mediated immune responses up to study day 390, induced by one or two doses of vaccine, by means of intracellular staining and flow cytometry.

    Time: up to Day 390

    Description: Occurrence of measles virus shedding as evidenced by a positive RT-PCR for saliva, nasal swab, urine, or blood sample in sentinel groups.

    Measure: To assess potential measles virus shedding by means of RT-qPCR of saliva, nasal swab, urine, or blood samples in sentinel groups on day 0 and up to day 42

    Time: up to Day 42

    Other Outcomes

    Description: Measles virus antibody levels as assessed by standard ELISA assays on day 0 and day 28.

    Measure: To assess the anti-measles antibody levels at baseline and on day 28 by ELISA

    Time: up to Day 28

    Description: SARS-CoV-2 N protein specific antibody up to study day 390 as measured by ELISA to differentiate the response to the COVID-19 vaccine from infection

    Measure: To assess the natural exposure of the subjects to SARS-CoV-2 during the duration of the trial by means of N protein-specific ELISA

    Time: Day 390

    Description: Occurrence of confirmed COVID-19 (i.e. asymptomatic, paucisymptomatic or symptomatic) cases in the study participant all along the study period

    Measure: To assess the occurrence of COVID-19 cases in study participants all along the duration of the study

    Time: Day 390
    13 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
    14 A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of a Prophylactic SARS-CoV-2 RNA Vaccine (BNT162b3) Against COVID-19 Using Different Dosing Regimens in Healthy Adults

    This trial has two parts. Part A, a dose finding part, with three dose escalation cohorts, one dose de-escalation cohort, three dose refinement cohorts, and up to three optional cohorts in older subjects. Part B, a part with expansion cohorts with dose levels which are selected using data generated in Part A. The vaccine BNT162b3 will be administered using a Prime/Boost (P/B) regimen.

    NCT04537949
    Conditions
    1. Covid-19
    2. Protection Against COVID-19
    Interventions
    1. Biological: BNT162b3

    Primary Outcomes

    Measure: Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring up to 21±2 days after the prime immunization.

    Time: 21 days following dose administration

    Measure: The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the boost immunization.

    Time: 28 days following dose administration

    Secondary Outcomes

    Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.

    Measure: Functional antibody responses.

    Time: up to 365 days following dose administration

    Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.

    Measure: Fold increase in functional antibody titers.

    Time: up to 365 days following dose administration

    Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.

    Measure: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline.

    Time: up to 365 days following dose administration
    15 A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years

    This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.

    NCT04341389
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
    2. Other: Placebo
    MeSH:Adenoviridae Infections

    Primary Outcomes

    Measure: Occurrence of adverse reactions

    Time: 0-14 days post vaccination

    Measure: Anti SARS-CoV-2 S IgG antibody response(ELISA)

    Time: 28 days post vaccination

    Measure: Neutralizing antibody response to SARS-CoV-2

    Time: 28 days post vaccination

    Secondary Outcomes

    Measure: Occurrence of adverse events

    Time: 0-28 days post vaccination

    Measure: Occurrence of serious adverse reaction

    Time: 0-6 months post vaccination

    Measure: Anti SARS-CoV-2 S IgG antibody response(ELISA)

    Time: 0, 14 days and 6 months post vaccination

    Measure: Neutralizing antibody response to SARS-CoV-2

    Time: 0 and 6 months post vaccination

    Measure: Neutralizing antibody response to Ad5-vector

    Time: 0, 28 days and 6 months post vaccination

    Measure: IFN-γ ELISpot responses to SARS-CoV-2 spike protein

    Time: 0 and 28 days post vaccination
    16 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
    17 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
    18 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
    19 Reducing Morbidity and Mortality in Health Care Workers Exposed to SARS-CoV-2 by Enhancing Non-specific Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial

    A novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worsened by absenteeism of healthcare workers and other frontline staff (HCW). Strategies to prevent morbidity and mortality of HCW are desperately needed to safeguard continuous patient care. Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis (TB), with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, with reported morbidity and mortality reductions as high as 70%. We hypothesize that a BCG vaccination may reduce the morbidity and mortality of healthcare workers during the COVID-19 outbreak in South Africa.

    NCT04379336
    Conditions
    1. COVID-19
    2. Sars-CoV2
    Interventions
    1. Biological: Bacille Calmette-Guérin (BCG)
    2. Other: Placebo Comparator

    Primary Outcomes

    Description: To compare the incidence of HCWs hospitalized due to COVID-19 per arm.

    Measure: Incidence of HCWs hospitalized due to COVID-19 per arm

    Time: 52 weeks

    Secondary Outcomes

    Description: To determine the incidence of SARS-CoV-2 infection in HCW by molecular or serological testing (as available) at entry, 10, 26 and/or 52 weeks.

    Measure: Incidence of SARS-CoV-2 infection per arm

    Time: 52 weeks

    Description: To compare the incidence of symptoms of upper respiratory tract infection per arm.

    Measure: Incidence of upper respiratory tract infections per arm

    Time: 52 weeks

    Description: To compare the number of days of (unplanned) absenteeism because of documented SARS-CoV-2 infection, COVID-19 or any reason per arm.

    Measure: Days of unplanned absenteeism due to COVID-19 or any reason per arm

    Time: 52 weeks

    Description: To compare the incidence of hospitalization of HCW for any reason per arm.

    Measure: Incidence of hospitalization for any reason per arm

    Time: 52 weeks

    Description: To compare the incidence of intensive care admission of HCW due to COVID-19 or any reason per arm.

    Measure: Incidence of intensive care unit admission per arm

    Time: 52 weeks

    Description: To compare the incidence of death of HCW due to COVID-19 or any reason per arm.

    Measure: Incidence of death per arm

    Time: 52 weeks

    Description: To describe the prevalence of latent TB infection as determined by interferon gamma release assay (IGRA) at enrolment and at week 52.

    Measure: Prevalence of latent TB infection

    Time: 52 weeks

    Description: To compare the incidence of active TB of HCW per arm.

    Measure: Incidence of active TB per arm

    Time: 52 weeks

    Description: To compare the effect of latent TB infection on morbidity and mortality of HCW due to COVID-19 per arm. The risk of morbidity and mortality of latent TB infected individuals is not known, we will examine whether there is a higher risk of disease severity and poor outcomes in this group.

    Measure: Compare the effect of latent TB on morbidity and mortality due to COVID-19 per arm

    Time: 52 weeks

    Description: To compare the incidence of grade 2 or higher adverse events and vaccination site reactions per arm.

    Measure: Incidence of treatment related adverse events

    Time: 52 weeks
    20 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
    21 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
    22 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
    23 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
    24 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
    25 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
    26 Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses

    SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.

    NCT04348370
    Conditions
    1. Coronavirus
    2. Coronavirus Infection
    3. Coronavirus as the Cause of Diseases Classified Elsewhere
    Interventions
    1. Biological: BCG Vaccine
    2. Biological: Placebo Vaccine
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: The primary outcome measure is the development of COVID19 infection. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of Covid-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert. defined as number of new cases during the 6 month time period

    Measure: Incidence of COVID 19 Infection

    Time: 6 months

    Secondary Outcomes

    Description: The secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based 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 criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.

    Measure: Disease Severity

    Time: up to 6 months
    27 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
    28 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
    29 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
    30 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)
    31 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
    32 A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

    This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older.

    NCT04405076
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: Biological: mRNA-1273: 50 mcg
    2. Other: Placebo
    3. Biological: Biological: mRNA-1273: 100 mcg

    Primary Outcomes

    Measure: Solicited local and systemic adverse reactions (ARs)

    Time: 7 days post-vaccination

    Measure: Unsolicited adverse events (AEs)

    Time: 28 days post-vaccination

    Measure: Medically-attended adverse events (MAAEs)

    Time: Month 0 through Month 13

    Measure: Serious adverse events (SAEs)

    Time: Month 0 through Month 13

    Measure: Change in the measure of clinical safety laboratory values in Cohort 2 from baseline

    Time: Through 1 month after last vaccination

    Measure: The number and percentage of participants with abnormalities in blood pressure, temperature, HR or respiratory rate will be assessed.

    Time: Through 1 year after last vaccination

    Measure: The number and percentage of participants with abnormalities in physical examinations will be assessed

    Time: Through 1 year after last vaccination

    Measure: Evaluate immunogenicity of mRNA-1273 by titer of SARS-CoV-2-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA)

    Time: Through 1 year after the final dose

    Secondary Outcomes

    Measure: Titer of SARS-CoV-2-specific neutralizing antibody (nAb)

    Time: Through 1 year post last vaccination

    Description: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer either from below the limit of detection (LOD) or lower limit of quantification (LLOQ) to equal to or above LOD or LLOQ, or a 4-times higher titer in participants with pre-existing nAb titers.

    Measure: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer

    Time: Through 1 year post last vaccination
    33 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
    34 A Phase I/II Randomized, Multi-Center, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults

    The SARS-CoV-2 virus is responsible for the COVID-19 pandemic. The pandemic emerged from Wuhan Province in China in December 2019 and was declared by the WHO Director-General a Public Health Emergency of International Concern on 30 January 2020. In this study, a vaccine developed by IIBR for SARS-CoV-2 virus will be assessed for its safety and potential efficacy in volunteers. The study is comprised of two phases, a dose-escalation phase (phase I) during which subjects (18-55 years old) will be randomly allocated to receive a single administration of IIBR-100 100 at low, mid or high dose or saline or two administrations of IIBR-100 at low dose, or saline, 28 days apart. Based on results obtained during phase I, and cumulative phase I data review, the expansion phase (phase II) will begin, during which larger cohorts as well as elderly age subjects will be randomly allocated to receive a single administration of IIBR-100 at low, mid or high dose or saline, or two administrations of IIBR-100 at low dose (prime-boost) or saline, 28 days apart. The subjects will be followed for a period of up to 12 months post last vaccine administration to assess the safety and efficacy of the vaccine.

    NCT04608305
    Conditions
    1. Covid19
    Interventions
    1. Biological: IIBR-100, low dose (prime)
    2. Biological: IIBR-100 medium dose (prime)
    3. Biological: IIBR-100 high-dose (prime)
    4. Biological: IIBR-100 low-dose (prime-boost)
    5. Other: Saline Placebo
    6. Other: Saline Placebo

    Primary Outcomes

    Description: Solicited events for 7 days after vaccination. Unsolicited events through 28 days after vaccination. SAEs 365 days after last vaccination New Onset Chronic Medical Condition (NOCMC) or Medically Attended AE (MAAE) 365 days after last vaccination.

    Measure: Phase I and II - The number, grade and percentage of study participants who experience any study injection-associated AEs or SAEs.

    Time: 365 days post last vaccination

    Measure: Phase II - IIBR-100 Immunogenicity as determined by GMT, GMFR, Seroconversion rates of the neutralizing antibody titers to SARS-CoV-2 per group at 28 days following last vaccination (in relation to Day 0-baseline).

    Time: 28 days post last vaccination

    Secondary Outcomes

    Description: Immunogenicity will be evaluated at the following days: 0, 7±2d, 14±2d, 28±4d, 56±5d, 84±4d, 168±14d and 365±14d after the first vaccination for single-dose groups (prime), and at days 0, 14±2d, 28±4d, 35±4d, 42±4d, 56±5d, 84±4d, 112±14d, 196±14d and 393±14d for the prime-boost groups

    Measure: Phase I and II - IIBR-100 Immunogenicity as determined by GMT, GMFR, Seroconversion rates of the neutralizing antibody titers to SARS-CoV-2 at baseline (day 0) and throughout the study

    Time: 365 days post last vaccination

    Description: Immunogenicity will be evaluated at the following days: 0, 7±2d, 14±2d, 28±4d, 56±5d, 84±4d, 168±14d and 365±14d after the first vaccination for single-dose groups (prime), and at days 0, 14±2d, 28±4d, 35±4d, 42±4d, 56±5d, 84±4d, 112±14d, 196±14d and 393±14d for the prime-boost groups

    Measure: Phase I and II - IIBR-100 immunogenicity as determined by GMT, GMFR, Seroconversion rates of the binding antibody titers to SARS-CoV-2 at baseline (day 0) and throughout the study

    Time: 365 days post last vaccination

    Description: Cellular immunity will be assessed at the following days: 0, 28±4d, 56±5d, 84±4d, 168±14d and 365±14d for single dose groups and at days 0, 56±5d, 84±4d, 112±14d, 196±14d and 393±14d for the prime-boost groups.

    Measure: Phase I and II - Cellular immunity as assessed by ELISPOT and ELISA.

    Time: 365 days post last vaccination

    Other Outcomes

    Measure: phase I and II - Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19, 14 days after having received on or two active vaccine injections

    Time: 14 days post last vaccination

    Measure: phase I and II - Number of virologically confirmed (PCR positive) severe cases of COVID-19, 14 days after having received on or two active vaccine injections

    Time: 14 days post last vaccination

    Measure: phase I and II - Number of serology confirmed symptomatic cases of COVID-19, 14 days after having received on or two active vaccine injections

    Time: 14 days post last vaccination

    Description: immunogenicity as determined by GMT, GMFR and seroconversion rates of the neutralizing, and binding, antibody titers to SARS-CoV-2 at 3, 6, 9 and 12 months after first vaccination, in a sub-group of subjects.

    Measure: phase I and II - Evaluate the kinetics of antibody decline based on temporal sub-group analyses (at 3, 6, 9, 12 months post first vaccination)

    Time: 365 days
    35 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
    36 A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy Adults

    The trial has two parts: Part A is for dose ranging with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older subjects. Part B is dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen.

    NCT04380701
    Conditions
    1. Infections, Respiratory
    2. Virus Diseases
    3. Infection Viral
    4. Vaccine Adverse Reaction
    5. RNA Virus Infections
    Interventions
    1. Biological: BNT162a1
    2. Biological: BNT162b1
    3. Biological: BNT162b2
    4. Biological: BNT162c2
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases RNA Virus Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Measure: Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21±2 days after the prime immunization.

    Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):

    Time: 21 days following dose administration

    Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 28±4 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.

    Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):

    Time: 28 days following dose administration

    Secondary Outcomes

    Description: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

    Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

    Time: up to 162 days following dose administration

    Description: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

    Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

    Time: up to 162 days following dose administration

    Description: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

    Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

    Time: up to 162 days following dose administration

    Description: Functional antibody responses at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.

    Measure: For BNT162c2 (SD):

    Time: up to 183 days following dose administration

    Description: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.

    Measure: For BNT162c2 (SD):

    Time: up to 183 days following dose administration

    Description: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.

    Measure: For BNT162c2 (SD):

    Time: up to 183 days following dose administration
    37 A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1)

    There is currently no treatment available for COVID-19, the acute respiratory illness caused by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19 that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA approved the use of convalescent plasma under the emergency investigational new drug (eIND) category. Randomized trials are needed to determine the efficacy and safety of COVID-19 convalescent plasma for acute COVID-19 infection. The objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19 convalescent plasma to adult patients admitted to hospital with COVID-19 infection at decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19. It is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma early in their clinical course will reduce the risk of death, and that other outcomes will be improved including risk of intubation, and length of ICU and hospital stay. This pan-Canadian clinical trial has the potential to improve patient outcomes and reduce the burden on health care resources including reducing the need for ICU beds and ventilators.

    NCT04348656
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Convalescent plasma

    Primary Outcomes

    Description: Endpoint of the need for intubation or patient death in hospital

    Measure: Intubation or death in hospital

    Time: Day 30

    Secondary Outcomes

    Description: Endpoint of the need for intubation before 30 days

    Measure: Need for Intubation

    Time: Day 30

    Description: Time in hours to intubation from randomization

    Measure: Time to intubation

    Time: Day 30

    Description: Endpoint of the number of days off ventilator at 30 days

    Measure: Ventilator-free days

    Time: Day 30

    Description: In-hospital death censored at 90 days

    Measure: In-hospital death

    Time: 90 days

    Description: Time to in-hospital death at 90 days

    Measure: Time to in-hospital death

    Time: Day 90

    Description: Death at 30 days

    Measure: Death at 30 days

    Time: 30 days

    Description: Date of intensive care unit admission (first date and total number of days)

    Measure: Length of stay in intensive care unit (ICU)

    Time: Day 30

    Description: Date of hospital admission (first date and total number of days)

    Measure: Length of stay in hospital

    Time: Day 30

    Description: First date on ECMO and total number of days

    Measure: Need for extracorpeal membrane oxygenation (ECMO)

    Time: Day 30

    Description: Need for renal replacement therapy

    Measure: Need for renal replacement therapy

    Time: Day 30

    Description: New myocarditis

    Measure: Development of myocarditis

    Time: Day 30

    Description: Transfusion-associated adverse events, Grade 3 and 4 serious adverse events, and cumulative incidence of Grade 3 and 4 adverse events and serious adverse events (using medDRA)

    Measure: Adverse events and serious adverse events

    Time: Day 30

    Description: CCP transfusion-associated adverse events (AE)

    Measure: CCP transfusion-associated adverse events (AE)

    Time: 30 days
    38 CONCOR-1: A Randomized Open-Label Trial of CONvalescent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness

    There is currently no treatment available for COVID-19, the acute respiratory illness caused by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19 that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA approved the use of convalescent plasma under the emergency investigational new drug (eIND) category. Randomized trials are needed to determine the efficacy and safety of COVID-19 convalescent plasma for acute COVID-19 infection. The objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19 convalescent plasma to adult patients admitted to hospital with COVID-19 infection at decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19. It is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma early in their clinical course will reduce the risk of death, and that other outcomes will be improved including risk of intubation, and length of ICU and hospital stay. WCM is a U.S. sub-site to this pan-Canadian clinical trial (NCT04348656) which has the potential to improve patient outcomes and reduce the burden on health care resources including reducing the need for ICU beds and ventilators.

    NCT04418518
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Convalescent plasma

    Primary Outcomes

    Description: Endpoint of the need for intubation or patient death in hospital

    Measure: Intubation or death in hospital

    Time: Day 30

    Secondary Outcomes

    Description: Endpoint of the need for intubation before 30 days

    Measure: Need for Intubation

    Time: Day 30

    Description: Time in hours to intubation from randomization

    Measure: Time to intubation

    Time: Day 30

    Description: Endpoint of the number of days off ventilator at 30 days

    Measure: Ventilator-free days

    Time: Day 30

    Description: In-hospital death censored at 90 days

    Measure: In-hospital death

    Time: 90 days

    Description: Time to in-hospital death at 90 days

    Measure: Time to in-hospital death

    Time: Day 90

    Description: Death at 30 days

    Measure: Death at 30 days

    Time: 30 days

    Description: Date of intensive care unit admission (first date and total number of days)

    Measure: Length of stay in intensive care unit (ICU)

    Time: Day 30

    Description: Date of hospital admission (first date and total number of days)

    Measure: Length of stay in hospital

    Time: Day 30

    Description: First date on ECMO and total number of days

    Measure: Need for extracorpeal membrane oxygenation (ECMO)

    Time: Day 30

    Description: Need for renal replacement therapy

    Measure: Need for renal replacement therapy

    Time: Day 30

    Description: New myocarditis

    Measure: Development of myocarditis

    Time: Day 30

    Description: Transfusion-associated adverse events, Grade 3 and 4 serious adverse events, and cumulative incidence of Grade 3 and 4 adverse events and serious adverse events (using medDRA)

    Measure: Adverse events and serious adverse events

    Time: Day 30

    Description: CCP transfusion-associated adverse events (AE)

    Measure: CCP transfusion-associated adverse events (AE)

    Time: 30 days
    39 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

    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.

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