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CoronavirusPhase 3NCT04536051

A Study of a Candidate COVID-19 Vaccine (COV003)

A Phase 3 study testing ChAdOx1 nCoV-19 single dose + paracetamol, MenACWY single dose + paracetamol and ChAdOx1 nCoV-19 two dose + paracetamol in people with Coronavirus, run by University of Oxford at 6 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Coronavirus
What is being tested?
ChAdOx1 nCoV-19 single dose + paracetamol, MenACWY single dose + paracetamol and ChAdOx1 nCoV-19 two dose + paracetamol
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,300 participants
Where
6 sitesBrazil
Study dates
2 Jun 2020to Sep 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults from 18 to 55 years of age
  • Adults aged 56-69 years old (after review of safety data by DSMB in this age group in the UK trial)
  • Adults aged 70 and above years old (after review of safety data by DSMB in this age group in the UK trial)
  • Able and willing (in the Investigator's opinion) to fulfill all study requirements;
  • Health professionals and adults at high risk of exposure to SARS-CoV-2, as defined in section 5.2 of this protocol;
  • Serology with SARS-CoV-2 negative IgG antibodies; This inclusion criteria does not apply to participants enrolled from version 4.0 of the protocol onwards.
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  • Willing to allow investigators to discuss the participant's clinical history with their GP/personal physician and access medical records relevant to the study procedures
  • Only for women of childbearing age willing to practice continuous effective birth control (see below) during the study, and a negative pregnancy test on the screening and vaccination day(s);
  • Consent to abstain from blood donation during the course of the study;
  • Provide informed consent in writing

Who cannot join

  • Participation in trials of prophylactic drugs for COVID-19 during the course of the study; Note: Participation in COVID-19 treatment trials is permitted in case of hospitalization due to COVID-19, after confirmation of positive PCR. The study team should be informed as soon as possible. Participants with COVID-19 not hospitalized with positive PCR results for COVID-19 may be medicated according to standard clinical practice.
  • Participation in SARS-CoV-2 serological research where participants are informed of their serological status during the course of the study;
  • Planned receipt of any vaccine (authorized or investigational), within 30 days before and after vaccination;
  • Prior receipt of an investigational vaccine or authorized with the possibility of impacting the interpretation of the study data (for example, vaccines vectorized by Adenovirus, any vaccines against coronavirus);
  • Administration of immunoglobulins and/or any blood products in the three months prior to the planned administration of the candidate vaccine;
  • Any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days);
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  • History of allergic disease or reactions possibly exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY or paracetamol;
  • Any history of angioedema;
  • Any history of anaphylaxis;
  • Pregnancy, lactation or willingness/intention to become pregnant during the study;
  • Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ);
  • History of severe psychiatric illness that possibly affects your participation in the study;
  • Hemorrhagic disorder (for example, factor deficiency, coagulopathy or platelet disorder), or a previous history of significant bleeding or bruising after IM injections or venipuncture;
  • Current suspected or known dependence on alcohol or drugs;
  • Severe and/or uncontrolled cardiovascular diseases, respiratory diseases, gastrointestinal diseases, liver disease, kidney disease, endocrine disorder, and neurological disease (mild/moderate well-controlled comorbidities are allowed);
  • History of COVID-19 confirmed by laboratory;
  • Seropositive for antibodies to SARS-CoV-2 before recruitment; This exclusion criteria does not apply to participants enrolled from version 4.0 of the protocol onwards
  • Continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban);
  • Any other significant illness, disorder or finding that may significantly increase the risk for the participant, affect his/her ability to participate in the study or impair the interpretation of the study data.
  • Re-vaccination exclusion criteria (two-dose groups only)
  • Anaphylactic reaction following administration of vaccine
  • Pregnancy

Trial locations and contacts

6 sites in 1 country.

Volunteer Recruitment Coordinator contact

01865 611424

vaccinetrials@ndm.ox.ac.uk

6 sites in 1 country

Brazil6 sites, 6 recruiting

  • Centro de Pesquisas Clinicas de Natal (CPCLIN)

    Natal, Rio Grande do Norte, 59025-050

    Eveline Pipolo Milan

    Recruiting

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

    Eduardo Sprinz

    Recruiting

  • Instituto D'Or de Pesquisa e Ensino - I'Dor

    Rio de Janeiro, 22281-100

    Ana Maria Pitella de Souze Leite

    Recruiting

  • Instituto D'Or de Pesquisa e Ensino - I'Dor

    Salvador, Estado de Bahia, 41253-190

    Ana Verena Mendes

    Recruiting

  • Universidade Federal de Santa Maria (UFSM)

    Santa Maria, Rio Grande do Sul, 97105-900

    Alexandre Vargas Schwarzbold

    Recruiting

  • CRIE, Universidade Federal de São Paulo

    São Paulo, 04038-001

    Lily Weckx

    Recruiting

Other trials in Brazil

About this study

Official title: A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine

A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.

Read the detailed description

There will be 2 study groups and an anticipated enrolment of 10,300 health professionals and adults with high potential for exposure to SARS-CoV-2, aged ≥18 years.

All subjects will undergo follow-up for a total of 1 year post last vaccination. Additional visits or procedures may be performed at the discretion of the investigators, e.g., further medical history and physical examination, or additional blood tests and other investigations if clinically relevant

Conditions
Coronavirus
Being tested
ChAdOx1 nCoV-19 single dose + paracetamol, MenACWY single dose + paracetamol, ChAdOx1 nCoV-19 two dose + paracetamol, MenACWY prime & saline placebo boost + paracetamol
Keywords
Covid-19, ChAdOx1 nCov19, sars-cov-2, vaccine
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChAdOx1 nCoV-19 single dose + paracetamolBiological

    Single dose of ChAdOx1nCOV19 vaccine, 5x10^10 vp + paracetamol

  • MenACWY single dose + paracetamolBiological

    Single dose of MenACWY + paracetamol

  • ChAdOx1 nCoV-19 two dose + paracetamolBiological

    Two dose of ChAdOx1 nCoV-19 vaccine, 5x10^10vp (prime) and 0.5mL boost (3.5 - 6.5 × 10^10 vp), 4-12 weeks apart + paracetamol

  • MenACWY prime & saline placebo boost + paracetamolBiological

    MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol

Study groups in NCT04536051
Study groupRoleWhat they receive
Group 1a: single dose ChAdOx & paracetamolExperimentalParticipants will receive a single standard dose of ChAdOx1 nCOV19 vaccine plus paracetamol
Receives: Biological: ChAdOx1 nCoV-19 single dose + paracetamol
Group 1b: single dose MenACWY & paracetamolActive comparatorParticipants will receive a single dose of MenACWY plus paracetamol
Receives: Biological: MenACWY single dose + paracetamol
Group 1c: two dose ChAdOx & paracetamolExperimentalParticipants will receive two standard doses of ChAdOx1 nCoV-19 vaccine, 4-12 weeks apart, plus paracetamol
Receives: Biological: ChAdOx1 nCoV-19 two dose + paracetamol
Group 1d: two dose MenACWy/saline & paracetamolActive comparatorParticipants will receive MenACWY prime, and Saline Placebo boost (0.5mL) plus paracetamol
Receives: Biological: MenACWY prime & saline placebo boost + paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR

    COVID-19 virologically confirmed symptomatic cases (PCR positive).

    Measured: 12 months post final vaccination

Secondary outcomes (10)

  1. Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination

    Occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination (in a subset of 200 participants)

    Measured: 7 days post vaccination

  2. Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of serious adverse events

    Occurrence of serious adverse events

    Measured: 12 months post final vaccination

  3. Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of episodes; intensified disease

    Occurrence of episodes; intensified disease

    Measured: 12 months post final vaccination

  4. Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: hospitalization for COVID-19 disease confirmed by PCR

    Hospitalization for COVID-19 disease confirmed by PCR

    Measured: 12 months post final vaccination

  5. Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: COVID-19 serious disease confirmed by PCR

    COVID-19 serious disease confirmed by PCR

    Measured: 12 months post final vaccination

  6. Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: death associated with COVID-19 disease

    Death associated with COVID-19 disease

    Measured: 6 months

  7. Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates)

    Antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates).

    Measured: 12 months post final vaccination

  8. Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: antibodies against the SARS-CoV-2 spike protein (serum conversion rates)

    Antibodies against the SARS-CoV-2 spike protein (serum conversion rates)

    Measured: 12 months post final vaccination

  9. Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus

    Virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus

    Measured: 12 months post final vaccination

  10. Assess the cellular immunogenicity of ChAdOx1 nCoV-19 candidate vaccine

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

    Measured: 12 months post final vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2020
  2. Study start2 Jun 2020
  3. Primary completionSep 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
10,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04536051
Sponsor's protocol ID
COV003
Status last verified
Sep 2020
First submitted
1 Sep 2020
Last updated
27 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Costa Clemens SA, Bibi S, Marchevsky NG, Aley PK, Cappuccini F, Davies SA, Gonzalez I, Kelly SC, Mujadidi YF, Pipolo Milan E, Schwarzbold AV, Sprinz E, Voysey M, Weckx LY, Wright D, Bansal H, Bergagard MAS, Isaacs AJ, Kelly EJ, Lan D, Morgan S, Shankar NK, Shoemaker K, Villafana TL, Lambe T, Green JA, Pollard AJ. Immunogenicity and Safety of ChAdOx1 nCoV-19 (AZD1222) as a Homologous Fourth-Dose Booster: A Substudy of the Phase 3 COV003 Trial in Brazil. Mayo Clin Proc Innov Qual Outcomes. 2025 Jul 11;9(4):100642. doi: 10.1016/j.mayocpiqo.2025.100642. eCollection 2025 Aug.

    PubMed 40686533

  • Conlin K, Jenkin D, de Whalley P, Weckx LY, Folegatti PM, Bibi S, Lambe T, Aley PK, Pollard AJ, Voysey M, Costa Clemens SA; COV003 Study Group. Predictors of severity of SARS-CoV-2 infections in Brazil: Post hoc analyses of a randomised controlled trial. Vaccine. 2025 Jan 25;45:126582. doi: 10.1016/j.vaccine.2024.126582. Epub 2024 Dec 14.

    PubMed 39675209

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ChAdOx1 nCoV-19 single dose + paracetamol, MenACWY single dose + paracetamol and ChAdOx1 nCoV-19 two dose + paracetamol in people with Coronavirus, run by University of Oxford at 6 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Volunteer Recruitment Coordinator (01865 611424, vaccinetrials@ndm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR (time frame: 12 months post final vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04536051, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.

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