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Sections: Correlations,
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Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug2490 | Placebo Wiki | 0.58 |
drug1366 | Gam-COVID-Vac Wiki | 0.36 |
drug2805 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki | 0.29 |
Name (Synonyms) | Correlation | |
---|---|---|
drug3923 | mRNA-1273 Wiki | 0.28 |
drug2529 | Placebo Vaccine Wiki | 0.23 |
drug1592 | INO-4800 Wiki | 0.18 |
drug941 | Covigenix VAX-001 placebo Wiki | 0.16 |
drug3499 | Two dose MenACWY vaccine min. 4 weeks apart Wiki | 0.16 |
drug1586 | IMM-101 Wiki | 0.16 |
drug3947 | multipeptide cocktail Wiki | 0.16 |
drug97 | ARCT-021 Dose 1 Wiki | 0.16 |
drug241 | Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) Wiki | 0.16 |
drug790 | Cliniporator Wiki | 0.16 |
drug2994 | Saline-sodium citrate (SSC) buffer Wiki | 0.16 |
drug2633 | Preservative-free saline Wiki | 0.16 |
drug1367 | Gam-COVID-Vac Lyo Wiki | 0.16 |
drug385 | BNT162b2 Wiki | 0.16 |
drug1130 | ERUCOV-VAC Wiki | 0.16 |
drug103 | ARCT-021 single dose priming Wiki | 0.16 |
drug192 | AlloStim Wiki | 0.16 |
drug581 | COVI-VAC Wiki | 0.16 |
drug4131 | vaccine BCG Wiki | 0.16 |
drug99 | ARCT-021 Dose 3 Wiki | 0.16 |
drug739 | ChAdOx1 nCoV-19 single dose + paracetamol Wiki | 0.16 |
drug1652 | Information Wiki | 0.16 |
drug158 | Ad5-nCoV Wiki | 0.16 |
drug2936 | SARS-CoV-2 vaccine (inactivated) Wiki | 0.16 |
drug2504 | Placebo (two doses), priming Wiki | 0.16 |
drug2002 | MenACWY single dose + paracetamol Wiki | 0.16 |
drug3562 | V-SARS Wiki | 0.16 |
drug2919 | SARS-CoV-2 inactivated vaccine Wiki | 0.16 |
drug1395 | Group B (Placebo) Wiki | 0.16 |
drug740 | ChAdOx1 nCoV-19 two dose + paracetamol Wiki | 0.16 |
drug1394 | Group B (AG0302-COVID19) Wiki | 0.16 |
drug1391 | Group A (Placebo) Wiki | 0.16 |
drug160 | AdCOVID Wiki | 0.16 |
drug1358 | GLS-5310 Wiki | 0.16 |
drug3497 | Two dose ChAdOx1 nCoV-19/Covishield 0.5mL Wiki | 0.16 |
drug1921 | MMR vaccine Wiki | 0.16 |
drug1818 | Licensed seasonal influenza vaccine Wiki | 0.16 |
drug2278 | Observation Wiki | 0.16 |
drug1641 | Inactivated SARS CoV 2 vaccine (Vero cell). Wuhan Wiki | 0.16 |
drug2003 | MenACWY vaccine Wiki | 0.16 |
drug367 | BCG vaccine Wiki | 0.16 |
drug2711 | QazCovid-in®-vaccine against COVID-19 Wiki | 0.16 |
drug1588 | IN01 vaccine Wiki | 0.16 |
drug98 | ARCT-021 Dose 2 Wiki | 0.16 |
drug364 | BCG Wiki | 0.16 |
drug102 | ARCT-021 Dose Regimen 2 Wiki | 0.16 |
drug653 | COVID19 vaccine Wiki | 0.16 |
drug2570 | Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine Wiki | 0.16 |
drug365 | BCG GROUP Wiki | 0.16 |
drug1390 | Group A (AG0302-COVID19) Wiki | 0.16 |
drug736 | ChAdOx1 nCoV-19 0.5mL prime plus boost Wiki | 0.16 |
drug2787 | Randomized booster Wiki | 0.16 |
drug2001 | MenACWY prime & saline placebo boost + paracetamol Wiki | 0.16 |
drug3498 | Two dose MenACWY vaccine Wiki | 0.16 |
drug1585 | IL-12 plasmid Wiki | 0.16 |
drug2924 | SARS-CoV-2 rS/Matrix M1-Adjuvant Wiki | 0.16 |
drug164 | Adenovirus Type-5 Vectored COVID-19 Vaccine Wiki | 0.16 |
drug557 | CELLECTRA® 2000 Wiki | 0.16 |
drug2806 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Wiki | 0.16 |
drug577 | CORVax Wiki | 0.16 |
drug105 | ARCT-021 two lower dose priming Wiki | 0.16 |
drug101 | ARCT-021 Dose Regimen 1 Wiki | 0.16 |
drug734 | ChAdOx1 nCoV-19 (qPCR) Wiki | 0.16 |
drug104 | ARCT-021 two higher dose priming Wiki | 0.16 |
drug2254 | Normal saline 0.9% Wiki | 0.16 |
drug3987 | oral polio vaccine + information Wiki | 0.16 |
drug733 | ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost Wiki | 0.16 |
drug732 | ChAdOx1 nCoV-19 (Abs 260) Wiki | 0.16 |
drug2382 | PLACEBO GROUP Wiki | 0.16 |
drug3422 | Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine Wiki | 0.16 |
drug623 | COVID-19 convalescent plasma Wiki | 0.16 |
drug1643 | Inactivated SARS-CoV-2 vaccine (Vero cell) Wiki | 0.16 |
drug100 | ARCT-021 Dose 4 Wiki | 0.16 |
drug928 | Covax-19™ Wiki | 0.16 |
drug159 | AdCLD-CoV19 Wiki | 0.16 |
drug3496 | Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL Wiki | 0.16 |
drug1364 | GX-19 Wiki | 0.16 |
drug2777 | RUTI® vaccine Wiki | 0.16 |
drug2530 | Placebo booster Wiki | 0.16 |
drug940 | Covigenix VAX-001 Wiki | 0.16 |
drug2985 | Saline Wiki | 0.14 |
drug2930 | SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki | 0.11 |
drug731 | ChAdOx1 nCoV-19 Wiki | 0.11 |
drug899 | Convalescent plasma Wiki | 0.11 |
drug4042 | rAd26-S Wiki | 0.11 |
drug678 | CVnCoV Vaccine Wiki | 0.11 |
drug3523 | UB-612 Wiki | 0.11 |
drug80 | AG0301-COVID19 Wiki | 0.11 |
drug4004 | placebo Wiki | 0.09 |
drug1642 | Inactivated SARS-CoV-2 Vaccine (Vero cell) Wiki | 0.09 |
drug81 | AG0302-COVID19 Wiki | 0.09 |
drug157 | Ad26.COV2.S Wiki | 0.09 |
drug384 | BNT162b1 Wiki | 0.09 |
drug3574 | VPM1002 Wiki | 0.09 |
drug366 | BCG Vaccine Wiki | 0.08 |
drug128 | AZD1222 Wiki | 0.07 |
Name (Synonyms) | Correlation | |
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D018352 | Coronavirus Infections NIH | 0.38 |
D007239 | Infection NIH | 0.35 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.33 |
Name (Synonyms) | Correlation | |
---|---|---|
D000257 | Adenoviridae Infections NIH | 0.21 |
D014777 | Virus Diseases NIH | 0.20 |
D005355 | Fibrosis NIH | 0.16 |
D006331 | Heart Diseases NIH | 0.16 |
D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.16 |
D018746 | Systemic Inflammatory Response Syndrome NIH | 0.16 |
D014115 | Toxemia NIH | 0.16 |
D018805 | Sepsis NIH | 0.16 |
D003327 | Coronary Disease NIH | 0.16 |
D008173 | Lung Diseases, Obstructive NIH | 0.16 |
D011658 | Pulmonary Fibrosis NIH | 0.16 |
D012141 | Respiratory Tract Infections NIH | 0.08 |
D003141 | Communicable Diseases NIH | 0.07 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002206 | Pulmonary fibrosis HPO | 0.16 |
HP:0006510 | Chronic pulmonary obstruction HPO | 0.16 |
HP:0006536 | Pulmonary obstruction HPO | 0.16 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0100806 | Sepsis HPO | 0.16 |
HP:0011947 | Respiratory tract infection HPO | 0.08 |
Navigate: Correlations HPO
There are 39 clinical trials
This is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.
Description: All confirmed COVID -19 cases 14 days after the full course of vaccination among healthy population aged between 18 and 85 years old.
Measure: Incidence of COVID-19 cases after two-doses of vaccination Time: 14 days after the full course of vaccinationDescription: The protective level of Anti-SARS-CoV-2 NtAbs
Measure: Anti-SARS-CoV-2 neutralizing antobody (NtAb) (immunological surrogate endpoint) Time: 14 days after 2-dose of immunization.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
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 180Description: 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 57Description: 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 36Description: 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 180Description: 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 29Description: 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 29Description: 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 57Bacillus 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).
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
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)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)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 .
Description: Occurrence of adverse reactions post vaccination
Measure: Safety indexes of adverse reactions Time: within 14 days post each vaccinationDescription: Evaluate the Geometric mean titer (GMT) of IgG antibody
Measure: Immunogencity indexes of GMT Time: Day 28 post the second vaccinationDescription: Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Measure: Immunogencity indexes of neutralizing antibody Time: Day 28 post the second vaccinationDescription: Occurrence of adverse reactions post-vaccination
Measure: Safety indexes of adverse events Time: Day 0-7,0-14,0-28 post each vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: Occurrence of serious adverse events post-vaccination
Measure: Safety indexes of SAE Time: Within 6 months post the second vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationThe objective is to determine the safety and immunogenicity of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19.
Description: The number and proportion of subjects with adverse events observed until Day 43 post 1st vaccination are declared to be primary target variables.
Measure: To assess the safety and tolerability of the COVID-19 vaccine Time: 43 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s).
Measure: Specific antibody response induced by the vaccine against the SARS-CoV-2 virus Time: 12 monthsDescription: Serum Neutralizing antibody levels.
Measure: Neutralizing Antibodies Levels Time: 12 monthsDescription: Serum TNF-alpha levels.
Measure: TNF-alpha Levels Time: 12 monthsDescription: Serum IFN-γ levels.
Measure: Interferon Levels Time: 12 monthsDescription: Serum IL-2, -4, -5, -6 levels.
Measure: Interleukine Levels Time: 12 monthsUntil the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses. Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them. For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.
Description: Incidence of COVID-19 cases confirmed or probable in the study population
Measure: Primary outcome Time: From date of randomization to 360 day of the studyDescription: Incidence of severe or critical infection in COVID-19 cases
Measure: Secondary outcome Time: From date to diagnosis to 1 month afterDescription: Lethality of the infection in both groups
Measure: Secondary outcome Time: From date to diagnosis to 1 month afterDescription: Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination
Measure: Secondary outcome Time: From date of randomization to 7 day of the studyDescription: Prevalence of SARS-Cov-2 infection
Measure: Secondary outcome Time: At baseline evaluationThe 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .
Description: Occurrence of adverse reactions post-vaccination
Measure: Safety indexes of adverse reactions Time: 0-7 days post-vaccinationDescription: Occurrence of adverse events post-vaccination
Measure: Safety indexes of adverse events Time: 0-28 days post-vaccinationDescription: Occurrence of serious adverse events post-vaccination
Measure: Safety indexes of SAE Time: 0-28 days, within 6 mouths post-vaccinationDescription: Occurrence of abnormal changes of laboratory safety examinations
Measure: Safety indexes of lab measures Time: pre-vaccination, day 7 post-vaccinationDescription: Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of GMT(ELISA) Time: day14,28,month 3,6 post-vaccinationDescription: Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of GMT(pseudoviral neutralization test method) Time: day14,28,month 6 post-vaccinationDescription: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of seropositivity rates(ELISA) Time: day14,28,month 3,6 post-vaccinationDescription: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) Time: day14,28,month 6 post-vaccinationDescription: Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of GMI(ELISA) Time: day14,28,month 3,6 post-vaccinationDescription: Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of GMI(pseudoviral neutralization test method) Time: day14,28,month 6 post-vaccinationDescription: Geometric mean concentration(GMC)of anti-Ad5 vector neutralizing antibody responses
Measure: Immunogencity indexes of GMC(Ad5 vector) Time: day、14,28,month3,6 post-vaccinationDescription: Geometric mean fold increase(GMI)of anti-Ad5 vector neutralizing antibody responses
Measure: Immunogencity indexes of GMI(Ad5 vector) Time: day、14,28,month3,6 post-vaccinationDescription: specific cellular immune responses
Measure: Immunogencity indexes of cellular immune Time: day 14, 28,month 6 post-vaccinationDescription: Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method
Measure: Consistency analysis(ELISA and pseudoviral neutralization test method) Time: day,14,28, month 6 post-vaccinationDescription: Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups
Measure: Dose-response relationship(Humoral immunity) Time: day14,28,month 3,6 post-vaccinationDescription: Persistence analysis of anti-S protein antibodies among study groups
Measure: Persistence analysis of anti-S protein antibodies Time: day14,28,month 3,6 post-vaccinationDescription: Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.
Measure: Time-dose-response relationship(Humoral immunity) Time: day14,28,month 3,6 post-vaccinationDescription: Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups
Measure: Dose-response relationship( cellular immunity) Time: day 14, 28,month 6 post-vaccinationDescription: Persistence analysis of specific cellular immune response
Measure: Persistence analysis of cellular immuse Time: day 14, 28,month 6 post-vaccinationDescription: Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.
Measure: Time-dose-response relationship(cellular immunity) Time: day 14, 28,month 6 post-vaccinationTo date, there is no vaccine or treatment with proven efficiency against COVID-19, and the transmissibility of the SARS-CoV-2 virus can be inferred by its identification in the oro-nasopharynx. The bacillus Calmette Guérin (BCG) has the potential for cross-protection against viral infections. This study evaluates the impact of previous (priming effect, from the titer of anti-BCG interferon-gamma) or current BCG exposure (boost with intradermal vaccine) on 1) clinical evolution of COVID-19; 2) elimination of SARS-CoV-2 at different times and disease phenotypes; and 3) seroconversion rate and titration (anti-SARS-CoV-2 IgA, IgM, and IgG).
Description: Classified as mild, moderate and severe
Measure: Clinical evolution of COVID-19 Time: 45 days of symptoms onset or diagnosisDescription: Virus detection by PCR
Measure: SARS-CoV-2 elimination Time: 7 days of symptoms onset or diagnosisDescription: Titration of anti SARS-CoV-2 IgA, IgM and IgG
Measure: Seroconversion rate and titration Time: 7 days of symptoms onset or diagnosisDescription: Classified according to type and severity
Measure: Local and systemic adverse events to BCG vaccination Time: 3 monthsDescription: Virus detection by PCR
Measure: SARS-CoV-2 elimination Time: 21 days of symptoms onset or diagnosisDescription: Titration of anti SARS-CoV-2 IgA, IgM and IgG
Measure: Seroconversion rate Time: 21 days of symptoms onset or diagnosisDescription: Virus detection by PCR
Measure: SARS-CoV-2 elimination Time: 45 days of symptoms onset or diagnosisDescription: Titration of anti SARS-CoV-2 IgA, IgM and IgG
Measure: Seroconversion rate and titration Time: 45 days of symptoms onset or diagnosisRandomized, 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.
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 dayDescription: 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 dayDescription: 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 dayDescription: 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)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.
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 weeksDescription: 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 weeksDescription: 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 weeksDescription: Number of participants with moderate, severe or critical Covid-19 at week 6.
Measure: Clinical outcome and progression after vaccinations Time: 6 weeksThe 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.
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, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: Changing of of virus neutralizing antibody titer Time: at days 0,14, 28, 42Description: 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, 42The objective of this randomized clinical trial is to test whether administration of live attenuated MMR vaccine (measles mumps rubella; Merck) to eligible adults at highest risk for contracting COVID-19 (healthcare workers, first responders), can induce non-specific trained innate immune leukocytes that can prevent/dampen pathological inflammation and sepsis associated with COVID-19-infection, if exposed.
Description: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline
Measure: Induction of myeloid-derived suppressor cells (MDSCs) Time: 14 days post-vaccinationDescription: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline
Measure: Induction of MDSCs Time: 30 days post vaccinationDescription: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline
Measure: Induction of MDSCs Time: 60 days post vaccinationDescription: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline
Measure: Induction of MDSCs Time: 12 months post vaccinationDescription: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection
Measure: COVID-19 infection positive Time: 14 days post-vaccinationDescription: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection
Measure: COVID-19 infection positive Time: 30 days post-vaccinationDescription: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection
Measure: COVID-19 infection positive Time: 60 days post-vaccinationDescription: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection
Measure: COVID-19 infection positive Time: 12 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 14 days post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 30 days post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 60 days post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 3 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 4 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 5 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 6 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 7 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 8 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 9 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 10 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 11 months post-vaccinationDescription: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)
Measure: Health questionnaire Time: 12 months post-vaccinationthe 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.
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, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: The changing of virus neutralizing antibody titer Time: at days 0, 14, 28, 42Description: 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, 28This 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
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 vaccinationDescription: 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 vaccinationDescription: 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 vaccinationDescription: 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 groupDescription: 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 groupDescription: 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 groupDescription: 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 groupDescription: 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 groupDescription: 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 groupDescription: 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 groupDescription: 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 groupDescription: 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 groupDescription: 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 groupSafety 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.
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 DaysDescription: 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 DaysDescription: Clinical well-being assessed by CTCAE v4.0
Measure: Lack of adverse events as per CTCAE v4.0 Time: 15 daysThis 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.
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 vaccinationDescription: Evaluate the incidence of severe adverse events (SAE)
Measure: Incidence of SAE Time: Within 12 monthsDescription: 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 vaccinationDescription: Incidence of solicited adverse reactions within 7 days after vaccination, in a subset
Measure: Incidence of solicited adverse reactions Time: Day 0-7 post vaccinationDescription: Incidence of unsolicited adverse events within 28 days after vaccination in a subset
Measure: Incidence of unsolicited adverse events Time: Day 0-28 post vaccinationDescription: The seroconversion rate of S-RBD IgG antibody post vaccination
Measure: Immunogencity of S-RBD IgG antibody (ELISA method) Time: Day 28 post vaccinationDescription: The seroconversion rate of neutralizing antibody
Measure: Immunogencity of neutralizing antibody Time: Day 28 post vaccinationDescription: Number of cell-mediated immune response against SARS-CoV-2
Measure: Cell-mediated immune profile Time: Day 28 post vaccinationThis 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.
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 42Description: 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 0-42Description: 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 0-196Description: 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 196Description: 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 196Description: 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 196Description: 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 196Randomized, 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.
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 daysDescription: 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 daysDescription: 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 doseDescription: 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 daysDescription: 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 daysThis clinical trial will evaluate the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2(COVID-19) in healthy volunteers.
Description: solicited/unsolicited local and systemic AEs after vaccination
Measure: Incidence of adverse events Time: Through 48 weeks post vaccinationDescription: Endpoint titer of binding antibody in serum
Measure: Geometric mean titer (GMT) of antigen-specific binding antibody titers Time: Through 48 weeks post vaccinationDescription: T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint
Measure: Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine Time: Through 48 weeks post vaccinationDescription: Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint
Measure: Geometric mean titer (GMT) of neutralizing antibody titers Time: Through 48 weeks post vaccinationDescription: Endpoint titer of binding antibody in serum at each timepoint
Measure: Determine IgG antibody responses after a single dose of vaccine related to treatment arm Time: Through 1 year post vaccinationDescription: Survival rate
Measure: Measure survival rate of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2. Time: Through 1 year post vaccinationDescription: Endpoint titer of binding antibody in serum at each timepoint Plaque-reduction neutralizing titer in serum at each timepoint T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint
Measure: Persistence of immune responses following vaccination with GLS-5310 Time: Through 1 year post vaccinationDescription: Change from baseline in binding antibody titers Change from baseline in T-cell response of antigen-specific interferon - gamma (IFN-γ) Change from baseline in plaque-reduction neutralizing titer(PRNT) in serum
Measure: Determine the extent of immune boosting for participants who are seropositive at baseline following vaccination with GLS-5310 Time: Through 1 year post vaccinationDescription: viral load measurement of blood and major organs
Measure: Measure viral load in organs, including blood, of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2. Time: Through 1 year post vaccinationDescription: pathological examination of organs
Measure: Perform histologic examination of organs of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2. Time: Through 1 year post vaccinationThis 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.
Description: Percentage of subjects with reactogenicity events
Measure: Reactogenicity Time: 14 days after each doseDescription: Percentage of subjects with adverse events
Measure: Adverse events Time: Days 1 through 57Description: Percentage of subjects with serious adverse events
Measure: Serious adverse events Time: Days 1-400Description: 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 400Description: Neutralising antibody level measured by microneutralisation assay in serum
Measure: Neutralizing antibody titre Time: Days 1, 15, 29, 43, 57, 120, 210, and 400Randomized, 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.
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 daysDescription: 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 daysDescription: 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 doseDescription: 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 doseDescription: 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 doseDescription: 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 daysDescription: 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 daysDescription: 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 doseThe 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
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, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: Changing of of virus neutralizing antibody titer Time: at days 0, 28, 42Description: Determination of antigen-specific cellular immunity
Measure: Changing of antigen-specific cellular immunity level Time: Time Frame: at days 0,28This 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.
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 57This 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.
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 2Description: 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 2Description: 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 doseDescription: 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 doseDescription: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values Time: 1 day after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 2Description: 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 1Description: 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 1Description: 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 2Description: 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 2Description: 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 2Description: 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 doseDescription: 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 doseDescription: 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 2Description: 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 2Description: 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 doseDescription: 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 doseDescription: 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 yearsDescription: 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 yearsDescription: 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 doseDescription: 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 doseDescription: 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 2Description: 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 2Description: 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 doseDescription: 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 doseDescription: 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 doseDescription: 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 doseDescription: 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 doseDescription: 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 doseDescription: 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 doseDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 doseThis study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
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 9Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Measure: Immunogenicity Time: Weeks 3, 5, 7, 9The 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.
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)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.
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)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 394Description: 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)The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed. Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection. This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers. A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.
Description: The primary outcome measure is the development of symptomatic COVID 19 infections. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of rt-PCR-confirmed symptomatic SARS-CoV-2 infection following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.
Measure: Incidence of symptomatic rt-PCR-confirmed SARS-CoV-2 infection Time: 6 monthsDescription: The secondary outcome measure is the development of Serology-confirmed infection with SARS-CoV-2. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of serology-confirmed SARS-CoV-2 following BCG vaccination compared to that following placebo, starting from 3 days post vaccination through 6 months.
Measure: incidence of Serology-confirmed infection with SARS-CoV-2 Time: 6 monthsDescription: In individuals who test positive for COVID-19, the proportion with severe disease following BCG vaccination compared to placebo, as defined by the following necessary care levels: non- hospital care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died.Additional WHO severity indicators of severe pneumonia, respiratory failure, sepsis, septic shock will also be included.
Measure: severity of COVID-19 disease Time: 6 monthsDescription: Incidence of self-reported symptomatic respiratory infections following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.
Measure: symptomatic respiratory infection Time: 6 monthsDescription: rates of 1) all cause respiratory infection 2) symptomatic COVID- 19, 3) serology-confirmed SARS-CoV-2 infection in health care workers.
Measure: effect of prior adult immunization with other vaccines associated with trained immunity Time: 6 monthsThis study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult volunteers.
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 9Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Measure: Immunogenicity Time: Weeks 3, 5, 7, 9This study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.
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 weeksDescription: 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 9Healthcare Workers (HCW) are at high risk for COVID-19. In addition to the risk of serious forms among HCW, significant absenteeism due to illness would have dramatic consequences in our ability to fight COVID-19. No coronavirus vaccine is available today and drug treatments are only at the start of clinical evaluation. Available since 1921, the bacillus Calmette and Guérin (BCG) is the most widely used vaccine in the world (> 3 billion doses administered) with an extremely low rate of adverse effects. BCG is indicated for the prevention of tuberculosis (TB), but more recent studies have shown that it also has nonspecific immune properties which may be interesting in the current COVID-19 epidemic. Data in mice and in humans have demonstrated protection conferred by BCG against viral respiratory infections such as influenza. In countries with high endemic TB, BCG decreases the incidence of acute respiratory infections by up to 80%, neonatal BCG vaccination has been shown to greatly reduce the risk of sepsis and of hospitalization of children for reasons other than TB. A recent study conducted in South Africa showed that re-vaccination with BCG in adults reduced the incidence of respiratory infections by 70% compared to unvaccinated controls. Beyond respiratory infections, BCG has also shown protective effects against inflammatory diseases. These non-specific beneficial effects are likely linked to the induction of "trained innate immunity", implying epigenetic and metabolic re-programming of innate immune cells. It is therefore possible that revaccination with BCG could significantly reduce the incidence and severity of COVID-19. Very recent ecological observations indeed suggest an inverse correlation between BCG vaccination coverage and the morbidity and mortality of COVID-19. In this context several trials began in Europe and Australia to evaluate the efficacy of BCG vaccination in populations at risk of exposure (HCW) or severe disease (elderly). This study is aligned with studies carried out in Australia, The Netherlands and Spain. In contrast to these latter studies, virtually all French study participants have been vaccinated in their childhood, since BCG vaccination was mandatory in France in neonates until 2007, and in HCW until recently. Therefore, the French study will be in a unique situation to evaluate the effect of re-vaccination with BCG in the context of BCG priming decades before revaccination.
Description: Documented COVID-19, i.e. symptomatic COVID-19 confirmed by either positive nasopharyngeal tests for SARS CoV2 and/or by thoracic tomodensitometry compatible with the diagnosis. and/or SARS CoV2 seroconversion
Measure: Incidence of documented COVID-19 among health care workers exposed to SARS CoV2 and vaccinated with BCG compared to placebo. Time: during the study period of 6 monthsDescription: Participants having developed a severe form of COVID-19, as defined by the necessity for hospitalization in ICU and O2 or artificial ventilation, or extracorporeal membrane oxygenation, or death
Measure: Numbers of COVID-19 patients requiring hospitalization in ICU and O2, artificial ventilation or extracorporal membrane oxygenation, or deaths in BCG-vaccinated health care workers compared to placebo Time: during the study period of 6 months.Description: Participants with seroconversion during the study, without symptoms related to COVID-19
Measure: Incidence of asymptomatic SARS CoV2 seropositive subjects among BCG-vaccinated health care workers compared to placebo. Time: during the study period of 6 months.Description: Participants presenting any kind of respiratory infection due to any cause
Measure: Incidence of subjects with any respiratory infection among BCG-vaccinated health care workers compared to placebo. Time: during the study period of 6 months.Description: Numbers of sick days and number of sick leaves
Measure: Numbers of sick days and numbers of sick leaves among BCG-vaccinated health care workers compared to placebo. Time: during the study period of 6 monthsDescription: Local and general events following BCG revaccination after BCG revaccination
Measure: Numbers of subjects with BCG-related advers events among BCG-vaccinated health care workers compared to placebo. Time: 30 days after BCG revaccinationDescription: Potentially modified markers of innate immunity upon SARS CoV-2 infection to be identified
Measure: Numbers and intensity of changes in innate immune markers after SARS CoV2 infection among BCG-vaccinated health care workers compared to placebo. Time: during the study period of 6 months.A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
Description: Counts and percentages of subjects with local and systemic events
Measure: Reactogenicity Time: For 7 days after vaccinationDescription: Counts and percentages of subjects with AEs
Measure: Adverse Events (AEs) Time: Day 1 to Day 57The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort, in healthy adults aged greater than or equal to 18 to less than or equal to 55 years and in adults aged greater than or equal to 65 years in good health with or without stable underlying conditions.
Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination Time: Day 8 (7 Days after first vaccination on Day 1)Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination Time: Day 64 (7 Days after second vaccination on Day 57)Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination Time: Day 8 (7 Days after first vaccination on Day 1)Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination Time: Day 64 (7 Days after second vaccination on Day 57)Description: Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination Time: Day 29 (28 Days after first vaccination on Day1)Description: Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination Time: Day 85 (28 Days after second vaccination)Description: SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measure: Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination Time: From Day 57 (vaccination 2) up to 1 yearDescription: SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measure: Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination Time: Day 1 (vaccination 1) up to 6 MonthsDescription: Number of participants with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported.
Measure: Cohorts 1, 2, and 3: Number of Participants With SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 38 MonthsDescription: Number of participants with SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
Measure: Cohorts 1, 2, and 3: Number of Participants with SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 38 MonthsDescription: Number of participants with Th-1 and Th-2 immune responses will be reported. Th1 and Th2 immune responses will be assessed by flow cytometry after SARS-CoV-2 S protein peptide stimulation of peripheral blood mononuclear cells (PBMCs) and intracellular staining [ICS] including cluster of differentiation (CD)-4+/CD-8+, Interferons (INF)-gamma, interleukin [IL] 2, Tumor Necrosis Factor (TNF)-alpha, IL-4, IL-5, IL-13, and/or other Th-1/Th-2 markers.
Measure: Cohorts 1, 2, and 3: Number of Participants with T-helper (Th)-1 and Th-2 Immune Responses as Assessed by Flow Cytometry Time: Up to 38 MonthsThe aim of this study is to investigate whether vaccination of healthcare professionals with VPM1002 could reduce the number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection). VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine. VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the new corona virus "SARS-CoV 2". A total of 1200 health care professionals (doctors, nurses and paramedical staff) with high expected exposure to SARSCoV-2 infected patients will receive a single dose of either VPM1002 or Placebo. All subjects will be requested to enter data regarding absenteeism, adverse events / serious adverse events, hospitalizations, intensive care unit admissions into an online questionnaire.
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 disease in participants at high risk of exposure to SARS-CoV-2. The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 6178 participants.
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.
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 daysDescription: 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 daysDescription: 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 daysDescription: Measured in days
Measure: Duration of hospitalization Time: 28 daysDescription: 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 daysDescription: 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 daysDescription: 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 hoursDescription: 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 daysThis protocol tests the safety and efficacy of a novel universal vaccine concept called "allo-priming" which is designed to protect elderly adults from progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses.
Description: vaccine events such as fever, rash, abnormal vital signs
Measure: frequency of vaccine events Time: day 0 to day 28Description: measurement of Th1/Th2 balance, allo-specific Th1/CTL response
Measure: Proportion of subjects with positive T-cell response Time: day 0 to 1 yearDescription: ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B
Measure: Proportion of subjects able to suppress viral propagation Time: day 0 to 1 yearThe purpose of this study is to identify early signals of efficacy or harm associated with convalescent plasma therapy in a population of Veteran inpatients with coronavirus disease 2019 (COVID-19).
Description: Death at any time after admission recorded in the electronic health record. Specific estimates of risk of death will be produced for 7 days, 14 days, 21 days and 28 days, and total deaths.
Measure: All-cause mortality Time: up to 28 daysDescription: Number of days from index date to first intubation in non-mechanically ventilated patients
Measure: Time to first intubation Time: 28 daysDescription: Number of days from index date to hospital discharge
Measure: Time to hospital discharge Time: 28 daysDescription: Number of days from index date to death from any cause
Measure: Time to all-cause mortality Time: 28 daysDescription: Long-term outcomes will include death at one year following the index date.
Measure: All-cause mortality Time: 1 yearAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports