Pandemic Planning in Pune: Distributing Study Medication during COVID-19
Date: 04/23/2020
The COVID-19 pandemic presents real challenges for research teams around the world conducting clinical trials. The experience with tuberculosis studies underway at the Byramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site (BJGMC-JHU CRS) in Pune, India, required swift action, agility, and innovation in ensuring that study participants continue to receive lifesaving care in the midst of a national lockdown.
The WHO has prioritized TB preventive therapy, including for household contacts of people with multidrug-resistant tuberculosis (MDR-TB), as a key strategy for controlling the epidemic. One study to prevent MDR TB among household contacts of confirmed cases currently underway at the BJGMC-JHU CRS is a multinational, phase 3, randomized clinical trial to compare 26 weeks of Delamanid (DLM) versus 26 weeks of Isoniazid (INH) for preventing confirmed or probable active TB in high-risk household contacts. For this trial, titled Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (or PHOENIx), 19 index MDR-TB cases and 12 household contacts are enrolled.
Participants on study routinely receive enough medication to last until their next scheduled clinical visit. With visits cancelled due to the lockdown, and with recovery from COVID-19 likely to be prolonged, the PHOENIx Team needed to find alternate ways to distribute medication. Mail delivery was not an option, and asking research participants to pick up medication from the CRS or at designated locations within the community was deemed too risky.