Milestones

Details

Date Event
Jul 20th 2020 Release of Interim Results
Jul 20th 2020 Launch of theprotect.com.pk
Jul 14, 2020 Peshawar as the 8th city
June 23rd 2020 Round 4 of training in Good Clinical Practices (GCP).
June 10th 2020 300 patients recruited.
May 24th - 27th 2020 The HQ arm of SOLIDARITY Trial by World Health Organization was temporarily paused. In view of this, a 72-hour safety review window was created to have the PROTECT data reviewed by National Data Safety & Management Board (NDSMB) notified dated 16.04.2020 by Drug Regulatory Authority of Pakistan (DRAP). During this window, recruitment was halted for the said arm and several rounds of reviews were undertaken to assess patient safety. Following these reviews to the satisfaction of reviewers, the recruitment for all arms of PROTECT was signaled. The SOLIDARITY study arrived at the same conclusion and soon resumed recruiting for all study arms.
May 20th 2020 200 patients recruited and Eid ul Fitr Newsletter issued.
May 5th 2020 100 patients recruited
April 24th 2020 First patient recruited Rawalpindi Medical University by Dr. Bilal Zafar
April 23rd 2020 Approval from NBC
April 21st 2020 Round 1 of training in Good Clinical Practices (GCP) for site researchers
April 17th 2020 First Study Sites visited i.e Rawalpindi Medical University (RMU) and Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU)-Pakistan Institute of Medical Sciences (PIMS) Islamabad
April 13th 2020 First approval granted by DRAP
April 5th 2020 Prospective registration at clinicaltrials.gov
March 30th 2020 Application to National Bioethics Committee (NBC) & Drug Regulatory Authority of Pakistan (DRAP) for the randomized study named PROTECT
March 24th 2020 Discussion on idea to test if HCQ monotherapy or in various combinations with Azithromycin and Oseltamivir works. Go-ahead given to develop study protocol and reach out to potential partners nationwide