Study registration: *
Publication Thiruvengadam R, SSRN, 2021
Dates: 2020-01-16 to 2021-05-31
Funding: Public/non profit (Department of Biotechnology, Government of India; Council for Scientific and Industrial Research, India; Fondation Botnar. Funding agencies did not have any role in the conception or conduct of the study.)
Conflict of interest: no COI (Declaration of Interests: None to declare. None of the authors were paid by any pharmaceutical company or any other agency to write this article.)

Methods

Study design:Test-negative
Description of participants: Individuals attending for RT-PCR testing for suspected SARS-CoV-2 infection at 2 centers in India
Inclusion criteria:
  • Individuals whith positive RT-PCR testing for suspected SARS-CoV-2 infection between April 1, 2021, to May 31, attended either at Employee State Insurance Corporation Medical College (ESICMC) Hospital or Translational Health Science and Technology Institute, Faridabad, India
  • The controls were selected randomly using a computer program from the individuals who tested negative, matched in numbers for each calendar week of testing during the study period.

Exclusion criteria:
  • NR

Follow-up duration (months): 4.5
Vaccines:
  • 2 IM doses of ChAdOx1-S , 4-6 weeks apart
Variant description :
Variant name: Delta
Evidence: Indirect evidence (prevalence of variant in the population: 90.98%)
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated: NR
Data accessibility: NR
General comment Concerns about uncontrolled confounding and potential for misclassification of vaccination status (collected by telephone interview after outcome assessment).