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ChAdOx1 nCoV-19Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (9)

Name (Synonyms) Correlation
drug1722 MenACWY boost Wiki 0.71
drug1847 Nebulized Platelet Lysate Wiki 0.71
drug1848 Nebulized Sterile Saline Wiki 0.71
drug641 ChAdOx1 nCoV-19 half boost Wiki 0.71
drug2053 Paracetamol Wiki 0.71
drug2970 Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days : Wiki 0.71
drug640 ChAdOx1 nCoV-19 full boost Wiki 0.71
drug1721 MenACWY Wiki 0.71
drug1923 Normal saline 0.9% Wiki 0.71

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials

1 A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers

A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM).

NCT04324606 Coronavirus Biological: ChAdOx1 nCoV-19 Biological: MenACWY Biological: ChAdOx1 nCoV-19 full boost Biological: ChAdOx1 nCoV-19 half boost Biological: MenACWY boost Drug: Paracetamol
MeSH:Coronavirus Infec Coronavirus Infections

Primary Outcomes

Description: Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases

Time: 6 months

Description: Occurrence of serious adverse events (SAEs) throughout the study duration

Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs)

Time: 6 months

Secondary Outcomes

Description: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms

Time: 7 days following vaccination

Description: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms

Time: 7 days following vaccination

Description: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs)

Time: 28 days following vaccination

Description: Change from baseline for safety laboratory measures (haematology and biochemistry blood results)

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests

Time: 6 months

Description: Occurrence of disease enhancement episodes

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes

Time: 6 months

Description: Number of deaths associated with COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19

Time: 6 months

Description: Number of hospital admissions associated with COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19

Time: 6 months

Description: Number of intensive care unit admissions associated with COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19

Time: 6 months

Description: Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates

Time: 6 months

Description: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays

Time: 6 months

Description: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)

Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19

Time: 6 months

Other Outcomes

Description: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus

Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through Virus neutralising antibody assays

Time: 6 months

Description: All safety, reactogenicity, immunogenicity and efficacy endpoints

Measure: Assess safety, reactogenicity, immunogenicity and efficacy endpoints, for participants receiving prophylactic paracetamol

Time: 6 months

Description: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) post boost

Measure: Assess immunogenicity of ChAdOx1 nCoV-19 given as homologous prime-boost

Time: 6 months

2 An Adaptive Phase I/II Randomized Placebo-controlled Trial to Determine Safety, Immunogenicity and Efficacy of Non-replicating ChAdOx1 SARS-CoV-2 Vaccine in South African Adults Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV

A Phase I/II, double-blinded, placebo-controlled, individually randomized trial to assess safety, immunogenicity and efficacy of the candidate Coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults aged 18-65 years living with and without HIV in South Africa. The vaccine or placebo will be administered via an intramuscular injection into the deltoid muscle of the non-dominant arm.

NCT04444674 Coronavirus Biological: ChAdOx1 nCoV-19 Biological: Normal saline 0.9%
MeSH:Coronavirus Infections

Primary Outcomes

Description: Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination. Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination

Measure: Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-negative adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety)

Time: Up to 12 months post enrollment

Description: Virologically-confirmed COVID-19 clinical disease will be defined as an acute respiratory illness that is clinically consistent with COVID-19 disease, AND SARS-CoV-2 RT-PCR positivity.

Measure: Determine if there is a reduction of severe and non-severe COVID-19 disease in HIV-negative adults who receive candidate vaccine ChAdOx1 nCoV-19 compared to placebo recipients (efficacy)

Time: Up to 12 months post enrollment

Description: Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination. Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination

Measure: Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-positive adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety)

Time: Up to 12 months post enrollment

Description: Assessing the Interferon-gamma (IFN-γ) enzyme- linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein and Th1 and Th2 cytokine response profile at 3-4 days after vaccination

Measure: Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in people living with HIV (immunogenicity)

Time: Up to 12 months post enrollment

Description: Assessing Enzyme-linked immunosorbent assay (ELISA) or fluorescence based micro-bead immunosorbent assay on luminex platform to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) and Virus neutralising antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus

Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19 in people living with HIV

Time: Up to 12 months post enrollment

Secondary Outcomes

Description: Assessing Enzyme-linked immunosorbent assay (ELISA) or fluorescence based micro-bead immunosorbent assay on luminex platform to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) and Virus neutralising antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus

Measure: Assess humoral Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity)

Time: Up to 12 months post enrollment

Description: Assessing the Interferon-gamma (IFN-γ) enzyme- linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein and Th1 and Th2 cytokine response profile at 3-4 days after vaccination

Measure: Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity)

Time: Up to 12 months post enrollment

Other Outcomes

Description: Cellular Fc effector functionality assays to measure the ability of vaccine elicited antibodies to mediate cellular cytotoxicity, complement deposition, and phagocytosis.

Measure: Assess Fc effector functionality in participants who receive ChAdOx1 nCoV-19 vaccine or placebo

Time: Up to 12 months post enrollment

Description: Flow cytometric sorting of plasmablasts and memory B cells to using spike and receptor binding domain "baits" to isolate SARS-CoV-2 specific B cells, sequence their immunoglobulin genes and define their epitope specificity.

Measure: Assess B cell responses to SARS-CoV-2 spike trimer and/or the receptor binding domain in participants who receive ChAdOx1 nCoV-19 vaccine or placebo

Time: Up to 12 months post enrollment

No related HPO nodes (Using clinical trials)