Pakistan Randomised Observational Trial to Evaluate Coronavirus Treatment (PROTECT) Underway

For Patient Enrollment Information

The pandemic of SARS Cov-2 (COVID-19) a condition characterized by array of symptoms leading to Severe Acute Respiratory Illness) began in the Central Chinese city of Wuhan (1). The first case was reported in December 2019 with symptoms resembling Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS). The pathogen was suspected to be from the family of enveloped positive-sense RNA viruses, characterized by club-like spikes that project from their surface, an unusually large RNA genome, and a unique replication strategy. As reported by Fehr AR et al in 2015, these viruses cause diseases in other mammals besides lethal respiratory tract infection in human beings. Chinese scientists sequenced the genome of this fast-emerging virus early in 2020 (2). It was named novel Corona virus 2019 causing an array of symptoms now referred to as COVID 19.

Considering the virulence potential and aggressive measures employed by the Chinese authorities to stem this deadly outbreak, World Health Organization has been issuing warnings before declaring it as a pandemic on March 11, 2020 (3).

The magnitude of problem is amplified by the absence of pharmaceutical solutions such as drugs and vaccines. For developing countries, the challenge is multifold (5).

A variety of drugs have been tested recently in search for a suitable cure including nafamostat, ribavirin, interferon, corticosteroids etc (2, 6). Chloroquine and hydroxychloroquine have been found to be efficient on COVID-19 and reported to be improving clinical symptoms in Chinese COVID-19 patients while similar effects have been demonstrated in French patients (6). Combining it with Oseltamivir  and Azithromycin has shown further promise in most recent studies (7). However, these findings are yet to be tested for the purpose in Pakistan where COVID-19 is being reported across. The rationale of such drug trial is merited by large population of 220 million and Pakistan’s proximity with Iran, one of the countries worst hit by ongoing pandemic. The PROTECT is on-going in Pakistan. 14 sites will be covered for the trials however, 4 site have been approved so far, and trial s have been conducted on 12 patients so far. This is the first Pre-peak trial.

PROTECT trial is evaluating the role of Hydroxychloroquine Phosphate/Sulfate, Oseltamivir and Azithromycin in COVID-19 infection through a comprehensive multicentre, cohort study at the centre of which is a multi-arm, multistage, open label randomised controlled trial. The on-going pandemic and limited evidence on effectiveness of chloroquine on local population warrant an adaptive trial design so that timely data analyses could promptly inform clinical strategy of containing COVID-19 (8). Hydroxychloroquine Phosphate/Sulfate (200 mg orally thrice a day for 5 days) vs Oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on Days 2-5) alone and in combination is being given to patients consenting to take part in the trial

The primary outcome will be clearing of coronavirus nucleic acid (COVID-19) from throat and nasal swabs checked by Reverse Transcription-Quantitative Polymerase Chain Reaction (RT-qPCR). Those not consenting to randomization will be followed up for outcomes of COVID-19 infection with supportive care only.

The comprehensive cohort study is underway in four different centres across Pakistan.

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