Covid 19 Research using Clinical Trials (Home Page)
Ad26.COV2.SWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug872 | Dexamethasone and Hydroxychloroquine Wiki | 0.58 |
| drug2666 | Spironolactone 100mg Wiki | 0.58 |
| drug2765 | Supportive Care Wiki | 0.33 |
| drug1730 | Mesenchymal Stromal Cells Wiki | 0.33 |
| drug2161 | Placebo oral tablet Wiki | 0.11 |
| drug2122 | Placebo Wiki | 0.09 |
| drug1284 | Hydroxychloroquine Wiki | 0.06 |
Correlated MeSH Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D055371 | Acute Lung Injury NIH | 0.17 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.16 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.14 |
| D013577 | Syndrome NIH | 0.06 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 3 clinical trials
Clinical Trials
1 A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older
The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort, in healthy adults aged greater than or equal to 18 to less than or equal to 55 years and in adults aged greater than or equal to 65 years in good health with or without stable underlying conditions.
NCT04436276 Healthy Biological: Ad26.COV2.S Biological: Placebo
Primary Outcomes
Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination Time: Day 8 (7 Days after first vaccination on Day 1)Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination Time: Day 64 (7 Days after second vaccination on Day 57)Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination Time: Day 8 (7 Days after first vaccination on Day 1)Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination Time: Day 64 (7 Days after second vaccination on Day 57)Description: Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination Time: Day 29 (28 Days after first vaccination on Day1)Description: Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.
Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination Time: Day 85 (28 Days after second vaccination)Description: SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measure: Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the First Vaccination Time: From Day 1 (vaccination 1) 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 MonthsSecondary Outcomes
Description: Number of participants with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported.
Measure: Cohorts 1, 2, and 3: Number of Participants With SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 38 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 MonthsDescription: Number of participants with Th-1 and Th-2 immune responses as assessed by enzyme-linked immunospot (ELISpot) will be reported. Th-1 and Th-2 will be assessed by dual or single IFN-gamma and IL-4 ELISpot assay after stimulation of peripheral blood mononuclear cell (PBMCs) with SARS-CoV-2 S protein peptides.
Measure: Cohorts 1, 2, and 3: Number of Participants With Th-1 and Th-2 Immune Responses as Assessed by ELISpot Time: Up to 38 Months2 A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
The purpose of the study is to demonstrate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in SARS-CoV-2 adult participants.
NCT04505722 Healthy Biological: Ad26.COV2.S Other: Placebo
Primary Outcomes
Description: Moderate defined as one sign and one symptom from a list of signs, such as respiratory rate >90 and symptoms such as shortness of breath or cough or 2 symptoms from a list of symptoms or Severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status Time: Up to 2.1 yearsSecondary Outcomes
Description: Moderate defined as one sign and one symptom from a list of signs, such as respiratory rate >90 and symptoms such as shortness of breath or cough or 2 symptoms from a list of symptoms or Severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus Time: Up to 2.1 yearsDescription: Moderate defined as one sign and one symptom from a list of signs, such as respiratory rate >90 and symptoms such as shortness of breath or cough or 2 symptoms from a list of symptoms or Severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly confirmed Moderate to Severe/Critical Coronavirus Disease COVID-19 with Seronegative Status Time: Day 2 (1 day post-vaccination)Description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination will be reported.
Measure: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention Time: Day 29 (28 days post- vaccination)Description: The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
Measure: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 Time: Day 29 (28 days post vaccination)Description: Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
Measure: Number of Participants with First Occurrence of Molecularly confirmed Mild COVID-19 Time: Day 29 (28 days post vaccination)Description: Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Measure: Number of Participants with First Occurrence of Molecularly confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized case Definition Time: Day 29 (28 days post vaccination)Description: Number of participants with first occurrence of molecularly confirmed COVID-19 with any severity (Moderate, Mild, severe/Critical) will be reported.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed COVID-19 with any Severity (Moderate, Mild, Severe/Critical) Time: Day 29 (28 days post vaccination)Description: Serologic conversion between baseline and 1 year post-vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
Measure: Serologic Conversion Between Baseline and 1- year Post-vaccination using an Enzyme-linked Immunosorbent Assay (ELISA) Time: Between baseline and 1-year post-vaccination (up to 52 weeks)Description: SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measure: Number of Participants with Serious Adverse Events (SAEs) Time: Up to 104 weeksDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Time: Up to 6 monthsDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Leading to Study Discontinuation Time: Up to 104 weeksDescription: Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Measure: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days after Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Measure: Number of Participants with Solicited Systemic AEs During 7 Days After Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination Time: Up to Day 29 (28 days after first vaccination on Day 1)Description: 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: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 104 weeksDescription: SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
Measure: SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 104 weeks3 A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Adults
The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) at 2-dose levels, as 2-dose schedule in healthy participants aged greater than or equal to 20 years in good health with or without stable underlying conditions.
NCT04509947 Healthy Biological: Ad26.COV2.S Biological: Placebo
Primary Outcomes
Description: Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically questioned and which are noted by participants in their diary for 7 days post first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling and induration 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: 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) AEs for which participants are specifically questioned and which are noted by participants in their diary for 7 days post second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling and induration 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: Number of Participants with Solicited Local 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 note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
Measure: 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 note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.
Measure: 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: Number of Participants with Unsolicited AEs for 28 days after First Vaccination Time: Day 29 (28 days after first vaccination on Day 1)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: Number of Participants with Unsolicited AEs for 28 days after Second Vaccination Time: Day 85 (28 days after second vaccination on Day 57)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: Number of Participants with Serious Adverse Events (SAEs) Time: Up to 12 monthsSecondary Outcomes
Description: SARS-CoV‑2 neutralization will be measured by VNA to analyse the neutralizing antibodies to the wild-type virus and/or pseudovirion expressing S protein.
Measure: Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Neutralization as measured by Virus Neutralization Assay (VNA) Time: Up to 12 monthsDescription: SARS-CoV-2 binding antibodies will be measured by ELISA to analyse the antibodies binding to the SARS-CoV-2 S protein.
Measure: SARS-CoV-2‑Binding Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) Time: Up to 12 months