A Clinical Study with GRAd-COV2 Vaccine for the Prevention of COVID-19 in Adults

COVID-19 A Phase II/III, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GRAd-COV2 Vaccine in Adults Aged 18 Years and Older - COVITAR

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005915-39-IT

Enrollment

10000

Registered

2021-03-01

Start date

2021-02-19

Completion date

Unknown

Last updated

2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects exposed to SARS-COV-2 risk of infectious

Interventions

Product Name: GRAd-COV2 Product Code: [GRAd-COV2] Pharmaceutical Form: Suspension for injection Current Sponsor code: GRAd-COV2 Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult female and male, 18 years of age or older at the time of consent 2. Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrollment 3. Able to understand and comply with study requirements/procedures based on the assessment of the investigator 4. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 5. Female participants, (a) Women of childbearing potential must: Have a negative pregnancy test on the day of screening and on Day 1; use one highly effective form of birth control for at least 28 days prior to Day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of study intervention. 6. Capable of giving signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2500

Exclusion criteria

Exclusion criteria: 1. History of allergy to any component of the vaccine 2. History of Guillain-Barré syndrome or any other demyelinating condition 3. Significant infection or other acute illness, including fever > 37.3 °C on the day prior to or day of randomization 4. History of laboratory-confirmed SARS-CoV-2 infection 5. Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia (only for phase II) 6. Recurrent severe infections and use of immunosuppressant medication within the past 6 months 7. History of primary malignancy except for: (a) Malignancy with low potential risk for recurrence after curative treatment (for example, history of childhood leukaemia) or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) Adequately treated uterine cervical carcinoma in situ without evidence of disease (d) Localized prostate cancer (only for phase II) 8. Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or vene puncture 9. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the Investigator (mild/moderate well-controlled comorbidities are allowed) (only for phase II) 10. Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data 11. Receipt of, or planned receipt of investigational or licensed products indicated for the treatment or prevention of SARS-CoV-2 or COVID-19 12. Receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention 13. Receipt of immunoglobulins and/or any blood products within 3 months prior to administration of study intervention or expected receipt during the period of study follow-up 14. Involvement in the planning and/or conduct of this study (applies to both Sponsor staff and/or staff at the study site) 15. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding 16. Has donated 450 ml or more of blood products within 30 days prior to randomization or expects to donate blood within 90 days of administration of study intervention.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary for Phase II Part of the study: 1) To assess the reactogenicity of a single or repeated (21 day apart) IM dose of GRAd-COV2 compared to placebo in adults of 18 years or more of age Phase III Part of the study: 2) To identify the schedule to be further studied in phase III by assessing antibody responses to S antigen following a single or repeated (21 days apart) IM dose of GRAd-COV2 or placebo (first 450 participants) Primary for Phase III Part of the study: 1) To estimate the efficacy of a single or repeated (21 days apart) IM dose of GRAd-COV2 compared to placebo for the prevention of COVID-19 in adults of 18 years or more of age;Secondary Objective: Secondary (study phase indicated in parenthesis) To estimate the efficacy of 1 single or repeated (21 days apart) IM dose of GRAd-COV2 compared to placebo for the prevention of severe or critical symptomatic COVID-19 (Phase III) Refer to the Study Protocol for the other secondary objectives section;Primary end point(s): Phase II Part of the study Incidence of local and systemic solicited AEs for 7 days post each dose of study intervention a) Post-treatment GMTs and GMFRs from day of dosing baseline value to 35 days post first dose in SARS-CoV-2 S and/or RBD antibodies b) Proportion of participants who have a post-treatment seroresponse (at least 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to the S and/or RBD antigens of GRAd-COV2. Phase III Part of the study A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs at least 28 days post first dose or or at least 7 days after the second dose of study intervention (depending on the selected regimen). Otherwise, a participant is not defined as a COVID-19 case. The endpoint will be treated as time to event Intercurrent events: The intercurrent events (ie, withdrawals before having met the primary efficacy endpoint, dea	—

Measure

Time frame

Main Objective: Primary for Phase II Part of the study: 1) To assess the reactogenicity of a single or repeated (21 day apart) IM dose of GRAd-COV2 compared to placebo in adults of 18 years or more of age Phase III Part of the study: 2) To identify the schedule to be further studied in phase III by assessing antibody responses to S antigen following a single or repeated (21 days apart) IM dose of GRAd-COV2 or placebo (first 450 participants) Primary for Phase III Part of the study: 1) To estimate the efficacy of a single or repeated (21 days apart) IM dose of GRAd-COV2 compared to placebo for the prevention of COVID-19 in adults of 18 years or more of age;Secondary Objective: Secondary (study phase indicated in parenthesis) To estimate the efficacy of 1 single or repeated (21 days apart) IM dose of GRAd-COV2 compared to placebo for the prevention of severe or critical symptomatic COVID-19 (Phase III) Refer to the Study Protocol for the other secondary objectives section;Primary end point(s): Phase II Part of the study Incidence of local and systemic solicited AEs for 7 days post each dose of study intervention a) Post-treatment GMTs and GMFRs from day of dosing baseline value to 35 days post first dose in SARS-CoV-2 S and/or RBD antibodies b) Proportion of participants who have a post-treatment seroresponse (at least 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to the S and/or RBD antigens of GRAd-COV2. Phase III Part of the study A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs at least 28 days post first dose or or at least 7 days after the second dose of study intervention (depending on the selected regimen). Otherwise, a participant is not defined as a COVID-19 case. The endpoint will be treated as time to event Intercurrent events: The intercurrent events (ie, withdrawals before having met the primary efficacy endpoint, dea

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Timepoint are reported within the endpoint list;Secondary end point(s): For relevant study phase please see section E.2 objective: Time to first SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring from 28 days post first dose or from 7 days after second dose of study intervention. 1. Proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time. 2. Time to first case of SARS-CoV-2 RT-PCR- positive symptomatic illness occurring from 28 days post first dose or from 7 days after second dose of study intervention using CDC criteria. 3. Time to first COVID-19-related Emergency Department admission occurring from 28 days post single dose or from 7 days post second dose of study intervention. 4. Time to COVID-19 related death occurring from 28 days post single dose or from 7 days post second dose of study intervention. 5a. Post-treatment GMTs and GMFRs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 S and/or RBD antibodies 5b. The proportion of participants who have a post-treatment seroresponse (at least 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to the S and/or RBD antigens of GRAd-COV2 6a. Post-treatment GMTs and GMFRs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 neutralizing antibodies. 6b. Proportion of participants who have a post-treatment seroresponse (at least 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to GRAd-COV2 as measured by SARS-CoV-2 neutralizing antibodies.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Timepoint are reported within the endpoint list;Secondary end point(s): For relevant study phase please see section E.2 objective: Time to first SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring from 28 days post first dose or from 7 days after second dose of study intervention. 1. Proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time. 2. Time to first case of SARS-CoV-2 RT-PCR- positive symptomatic illness occurring from 28 days post first dose or from 7 days after second dose of study intervention using CDC criteria. 3. Time to first COVID-19-related Emergency Department admission occurring from 28 days post single dose or from 7 days post second dose of study intervention. 4. Time to COVID-19 related death occurring from 28 days post single dose or from 7 days post second dose of study intervention. 5a. Post-treatment GMTs and GMFRs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 S and/or RBD antibodies 5b. The proportion of participants who have a post-treatment seroresponse (at least 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to the S and/or RBD antigens of GRAd-COV2 6a. Post-treatment GMTs and GMFRs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 neutralizing antibodies. 6b. Proportion of participants who have a post-treatment seroresponse (at least 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to GRAd-COV2 as measured by SARS-CoV-2 neutralizing antibodies.

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Countries

Argentina, Belgium, Brazil, Chile, Czechia, France, Germany, Indonesia, Italy, Malaysia, Poland, South Africa

Contacts

Public ContactUnità di sperimentazioni COVID

Istituto Nazionale Malattie Infettive L. Spallanzani

simone.lanini@inmi.it065582825

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 11, 2026