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    Covid19

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

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

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (14)


    Name (Synonyms) Correlation
    drug2919 SARS-CoV-2 inactivated vaccine Wiki 0.50
    drug1395 Group B (Placebo) Wiki 0.50
    drug1394 Group B (AG0302-COVID19) Wiki 0.50
    Name (Synonyms) Correlation
    drug1391 Group A (Placebo) Wiki 0.50
    drug2503 Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) Wiki 0.50
    drug369 BCG-10 vaccine Wiki 0.50
    drug16 0.9% saline Wiki 0.50
    drug1390 Group A (AG0302-COVID19) Wiki 0.50
    drug623 COVID-19 convalescent plasma Wiki 0.50
    drug1210 EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki 0.50
    drug157 Ad26.COV2.S Wiki 0.29
    drug385 BNT162b2 Wiki 0.25
    drug128 AZD1222 Wiki 0.22
    drug2490 Placebo Wiki 0.19

    Correlated MeSH Terms (5)


    Name (Synonyms) Correlation
    D018450 Disease Progression NIH 0.35
    D007239 Infection NIH 0.24
    D003141 Communicable Diseases NIH 0.20
    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.16
    D045169 Severe Acute Respiratory Syndrome NIH 0.10

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 4 clinical trials


    1 Simple, Blind, Placebo-controlled, Randomized Study of the Safety, Reactogenicity and Immunogenicity of Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), in Volunteers Aged 18-60 Years (I-II Phase)

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

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

    Primary Outcomes

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

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

    Time: throughout the study, an average of 270 days

    Secondary Outcomes

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

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

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

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

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

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

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

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

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

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

    Measure: Incidence and type of adverse events during the study

    Time: throughout the study, an average of 270 days

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

    Measure: Incidence of serious adverse events during the study

    Time: throughout the study, an average of 270 days

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

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

    Time: throughout the study, an average of 270 days
    2 Multi-center, Phase 3, Double-blind, Randomized, Placebo-controlled, Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of an Inactivated Vaccine Against the SARS-CoV-2 Infection in High Risk of Infection Adults

    The study will evaluate the efficacy, safety, and immunogenicity of an inactivated vaccine against the SARS-CoV-2 infection in high risk of infection adults. Two doses of the vaccine or placebo will be administered in an 0 and 14 days schedule. Follow-up of safety and efficacy will be implemented by 12 months after the first dose. Immunogenicity will be studied in a subgroup of participants.

    NCT04651790
    Conditions
    1. Covid19
    2. Vaccines
    Interventions
    1. Biological: SARS-CoV-2 inactivated vaccine
    2. Other: Placebo
    MeSH:Infection

    Primary Outcomes

    Description: Vaccine efficacy to prevent virologically confirmed COVID-19 two weeks after the second vaccination will be determined

    Measure: Incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second vaccination

    Time: Two weeks after second dose up to one year after first dose

    Description: The frequency of solicited and unsolicited local and systemic adverse reactions will be registered. This will be measured during the first 7 days after each vaccination. These adverse reactions will be registered according to the age group in adult (18-59 years old) and elder (60 years of age or older) subjects.

    Measure: Frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects.

    Time: During the first 7 days after each dose of vaccine/placebo

    Secondary Outcomes

    Description: The incidence of cases confirmed through PCR for COVID-19 after administration of at least one dose of vaccine/placebo will be determined.

    Measure: Incidence of cases of virologically confirmed COVID-19 after administration of at least one dose of vaccine/placebo

    Time: Since first dose and up to 12 months after

    Description: The incidence of severe cases of COVID-19, confirmed through PCR, two weeks after the second vaccination, will be determined.

    Measure: Incidence of severe cases of COVID-19 virologically confirmed two weeks after the second vaccination

    Time: Since two weeks after the second dose up 12 month after first dose

    Description: The incidence of hospitalized cases of COVID-19 two weeks after the second vaccination will be determined.

    Measure: Incidence of hospitalized cases of COVID-19 two weeks after the second vaccination

    Time: Since two weeks after the second dose and up 12 month after first dose

    Description: The incidence of deaths due to COVID-19 two weeks after the second vaccination will be determined.

    Measure: Incidence of deaths due to COVID-19 two weeks after the second vaccination

    Time: Since two weeks after the second dose up 12 month after first dose

    Description: The incidence of adverse reactions to the vaccine, both local and systemic, solicited and unsolicited will be determined. These adverse reactions will be measured within the period of four weeks after each dose of vaccination. These adverse reactions will be registered according to the age group in adult (18-59 years old) and elder (60 years of age or older) subjects.

    Measure: Incidence of adverse reactions to the vaccine, local and systemic, solicited and unsolicited, within the period of four weeks after each dose of vaccination, according to the age group, adults (18-59 years old) and elder (60 years or older) subjects.

    Time: Four weeks after each dose of vaccine/placebo

    Description: The frequency of severe COVID-19 cases in participants who received at least one dose of vaccine/placebo will be determined.

    Measure: Frequency of severe COVID-19 cases in participants who received at least one dose of vaccine/placebo

    Time: Since first dose up to 12 month after

    Description: The occurrence of serious adverse events (SAE) and adverse events of special interest in participants who have received at least one dose of the vaccine, will be determined.

    Measure: Incidence of serious adverse events (SAE) and adverse events in participants who have received at least one dose of the vaccine

    Time: Since first dose up to 12 month after

    Description: The cellular immune response in a subgroup of participants, before and two and four weeks after the administration of each dose of the vaccine, will be evaluated.

    Measure: Percentage of participants that show a significant increase in SARS-CoV-2 specific T cells after vaccination, determined by flow Cytometry and ELISPOT

    Time: Since first dose up to 4 weeks after second dose

    Description: The presence of anti-SARS-CoV-2 antibodies in a subgroup of participants, before and two weeks after the administration of each dose of the vaccine, will be evaluated.

    Measure: Percentage of participants with a significant increase of anti-SARS-CoV-2 antibodies, determined by ELISA

    Time: Since first dose up to 2 weeks after second dose
    3 Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study

    This is a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population. After randomization, the trial for each participant will last for approximately 13 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo will be given intramuscularly (IM) separated by 21 days.

    NCT04649021
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: BNT162b2
    2. Other: Placebo

    Primary Outcomes

    Description: SCR of SARS-CoV-2 serum neutralizing titers at 1-month after dose 2. Seroconversion is defined as ≥4-fold rise from before vaccination to 1-month post dose 2.

    Measure: SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR)

    Time: 1 Month after Dose 2

    Measure: The geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers at 1 month after dose 2

    Time: 1 Month after Dose 2

    Secondary Outcomes

    Description: Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 serum neutralizing titers - SCR

    Time: 1 Week, 6 and 12 Months after Dose 2

    Description: GMT of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 serum neutralizing titers - GMT

    Time: 1 Week, 6 and 12 Months after Dose 2

    Description: Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 anti-S1 immunoglobulin G (IgG) antibody level - SCR

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: GMT of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 anti-S1 IgG antibody level - GMT

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: Compared with baseline before Vaccination 1, the GMFR of SARS-CoV-2 serum neutralizing antibody titers at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 serum neutralizing antibody level - Geometric mean fold rise (GMFR)

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: Compared with baseline before Vaccination 1, GMFR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 anti-S1 IgG antibody level - GMFR

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

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

    Measure: Percentage of participants reporting local reactions

    Time: Within 7 Days and 14 Days after each vaccination

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

    Measure: Percentage of participants reporting systemic events

    Time: Within 7 Days and 14 Days after each vaccination

    Description: Percentage of participants with abnormal hematology laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.

    Measure: Hematology laboratory assessments

    Time: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2

    Description: Percentage of participants with abnormal chemistry laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.

    Measure: Chemistry laboratory assessments

    Time: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2

    Description: Percentage of participants with grading shifts in hematology laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.

    Measure: Hematology laboratory assessments

    Time: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2

    Description: Percentage of participants with grading shifts in chemistry laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.

    Measure: Chemistry laboratory assessments

    Time: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2

    Description: AEs from dose 1 to 1 month after the last dose.

    Measure: Adverse events (AEs)

    Time: From Dose 1 through 1 Month after the last Dose

    Description: SAEs from dose 1 to 6 months after the last dose.

    Measure: Serious AEs (SAEs)

    Time: From Dose 1 through 6 Months after the last Dose
    4 A Multi-centre, Randomised, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland

    Countries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes. The aim of the study is to answer the following questions: 1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)? 2. Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects? 3. Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result? A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of TB skin test/anti-SARS-CoV-2 IgG test/serum banking*; V3: TB skin test (TST) interpretation and subjects' division into three groups: (I) positive TST - observation; (II) negative TST- BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on randomisation; V4: serum banking*. Parallel beginning from V3, weekly telephone monitoring participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm SARS-CoV-2 infection + serum banking*. V5: 3 months after vaccination at the end of the study: history/anti-SARS-CoV-2 IgG test, serum banking*. Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST + observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should demonstrate whether mass BCG vaccination has an impact on the incidence and course of COVID-19. * to measure the level of cytokines involved in cell-mediated immunity process

    NCT04648800
    Conditions
    1. Covid19
    2. BCG Vaccination Reaction
    3. SARS-CoV Infection
    Interventions
    1. Drug: BCG-10 vaccine
    2. Drug: 0.9% saline
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: shock - when catecholamines are required despite initial fluid resuscitation severe respiratory failure - the need for non-invasive or invasive ventilation severe renal failure - the need for renal replacement therapy (for undialysed individuals, i.e. with end-stage renal failure (ESRD)

    Measure: death and life- or health-threatening condition (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe renal failure, stroke/transient cerebral ischaemia)

    Time: throughout the period of 18 months from inclusion

    Secondary Outcomes

    Description: Present symptoms (determined in the Telephone Contact Card) appear to indicate a possible SARS-CovV-2 infection

    Measure: Onset of clinical symptoms of COVID-19

    Time: 12 weeks from the date of the third visit - V3

    Description: based on anti SARS-CoV-2 IgG serological tests

    Measure: asymptomatic SARS-CovV-2 infection

    Time: 12 weeks from the date of the third visit - V3

    Description: the need for hospitalisation and its duration

    Measure: Hospitalisation

    Time: 12 weeks from the date of the third visit - V3

    Description: the need for hospitalisation in the ICU and its duration

    Measure: ICU Hospitalisation

    Time: 12 weeks from the date of the third visit - V3

    Description: requiring passive oxygen therapy to eliminate the symptom or maintain saturation >92%

    Measure: Dyspnoea

    Time: 12 weeks from the date of the third visit - V3

    No related HPO nodes (Using clinical trials)


    HPO

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


    No related HPO nodes (Using clinical trials)


    Reports

    Data processed on January 01, 2021.

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

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    Alphabetical index of all Terms

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