Trial CTRI/2020/08/027170
Publication Kulkarni P, EClinicalMedicine, 2021
Dates: 2020-08-25 to 2020-10-31
Funding: Mixed (Serum Institute of India Pvt Ltd, Indian Council of Medical Research, AstraZeneca)
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / India
Follow-up duration (months): 6
SII-ChAdOx1 (Covishield) (n = 900)
Placebo (adjuvant) (n = 300)
Inclusion criteria
  • Adults aged 18 years and older
  • individuals with controlled comorbid conditions, including diabetes and hypertension, and controlled cardiovascular, respiratory, hepatic, renal and neurological conditions were eligible
  • female participants were required to have a negative pregnancy test prior to enrolment and were required to use adequate contraception from 28 days before the first dose through 28 days after the second dose of vaccine
Exclusion criteria
  • Acute illness
  • known prior SARS-CoV-2 infection
  • an immunosuppressive condition or receipt of immunosuppressive therapy
Interventions
Intervention
2 IM doses of 5x10^10 vp, 28 days apart
Control
2 IM doses adjuvant, 28 days apart
Participants
Randomized
1200 participants
Characteristics of participants
Type of participants: Adults
N=1200
915 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 18-84
Description of participants
Adults (seronegative and seropositive)without a history of COVID and not immunocompromised at 14 centers in India
Primary outcome
In the register
Occurrence of causally related SAEs throughout the study duration following vaccination
In the report
Causally related SAEs (as assessed by both investigators and the sponsor) reported through the day 180 study visit
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: No
Data accessibility: corresponding author: Dr Prasad S Kulkarni, email: drpsk@seruminstitute.com
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
Low
General comment In addition to the published article, the protocol, statistical plan and prospective study registry were used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The target sample size specified in the registry was achieved. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The article reported on a study with two cohorts, this part of the study relates to the safety cohort. This trial was update in Mars 1st, 2022, after publication of the study report.