Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial
Objectives: To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8 hourly thrice a day for 5 days), versus oseltamivir (75 mg orally twice a day for 5 days), and versus Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus (COVID-19) nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes). Trial Design: An adaptive design, set within a comprehensive cohort study, to permit flexibility in this fastchanging clinical and public health scenario. The randomized study will be a multicenter, multiarm, multistage, randomized controlled trial with a parallel design. An observation only cohort will emerge from those not consenting to randomization.
Supplementary information Supplementary information accompanies this paper at https://doi.org/10. 1186/s13063-020-04616-4.
Ethics approval The proposed study is approved by the National Bioethics Committee of Pakistan on April 22, 2020 (reference No.4-87/NBC-471-COVID-19-05/20/) and IRBs at most of the participating sites. Remaining sites have endorsed the ethics approval of both University of Health Sciences Lahore and National Bioethics Committee (NBC). Participants' informed consent is intended to be sought on printed proforma designed in local language and no individual under the age of 18 years is to be enrolled. Certified that this trial has received ethical approval from the appropriate ethical committee as described above
Consent for publication Not Applicable
Competing interests The authors declare that they have no competing interests