Trial CTRI/2021/01/030416
Publication Khobragade A, Lancet , 2022
Dates: 2021-01-16 to 2021-06-23
Funding: Mixed (National Biopharma Mission, Department of Biotechnology, Government of India; Cadila Healthcare, Ahmedabad, Gujarat India; PharmaJet provided the PharmaJet Tropis needle-free injection system for vaccine delivery.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / India Follow-up duration (months): 5.2 | |
| 2 mg ZyCov-D (n=13851) Placebo (n=13852) |
|
| Inclusion criteria | Healthy subject of either gender ≥12 years of age; Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study; Ability to provide informed consent from the adult subjects or from the parents of paediatric subjects. Additionally, assent from paediatric subjects (Audio video recording in case of vulnerable subject); Adult subjects or parents of paediatric subjects literate enough to fill the diary card; Subjects with good health or with stable medical condition for chronic disease. (Stable condition is defined as there is no change in the medication or dose of medication or severity of disease from last 3 months before enrolment.); Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the follow-up visit and males will agree to use contraception; Willing to allow storage and future use of biological samples for future research. |
| Exclusion criteria | Febrile illness (temperature ≥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment; Laboratory confirmed SARS-CoV-2 positive; History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days; History of SARS/ MERS infection; Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine. 6. Past history of hypersensitivity reaction or any serious adverse event after any vaccination; Past history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy; Subjects with confirmed immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy; Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder; Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study; Any other vaccine administration within the last 30 days or planned to be administered during the study period; Pregnant and lactating women; Participation in another clinical trial in the past 3 months; History of drug / alcohol abuse. |
| Interventions | |
| Intervention
3 intradermal doses of 2mg ZyCoV-D, 28 days apart |
|
| Control
3 intradermal doses of placebo, 28 days apart | |
| Participants | |
| Randomized 27703 participants | |
| Characteristics of participants Type of participants: Adolescents and adults N=27703 18592 males Children: 935 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 12-88 | |
| Description of participants Healthy adults and adolescents aged (≥12 years) with no previous history of COVID-19 at 49 centers in India. | |
| Primary outcome | |
| In the register To demonstrate the efficacy of ZyCoV-D in the prevention of virologically confirmed symptomatic COVID-19 cases as compared to placebo. Timepoint Day 84 to Day 364. | |
| In the report The number of participants with first occurrence of symptomatic RT-PCR-positive COVID-19, 28 days after the third dose of ZyCoV-D vaccine, until the targeted number of cases (n=158) had been achieved. | |
| Variants description | |
Variants
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| Description * | |
| Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Variant delta: Some concerns |
| General comment | In addition to the published article, the prospective study registry and supplementary appendices were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The article reports an interim analysis triggered when 50% of COVID-19 events had been detected and thus the study (n = 27703) had not yet achieved its target sample size (n = 28216). There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. |