Date: 08-Oct-2020

Experts See Critical Value In US FDA Norms To Assess COVID-19 Symptoms In Outpatients For Clinical Trials

Medical experts from both government and private hospitals see the norms from US FDA to assess COVID-19-related symptoms in outpatients for clinical trials as a valuable source to identity the right patient.

As always, the global regulatory authority plays a critical role in protecting countries from threats such as emerging infectious diseases, including the COVID-19 pandemic. It has now issued a guidance to provide sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products. The drugs under investigation are to prevent or treat COVID-19 in outpatient adult and adolescent subjects.

The guidance is not intended for development programs evaluating products to treat or prevent post infectious COVID-19 conditions such as multisystem inflammatory syndrome in children or to development programs for preventative vaccines.

Given the magnitude of this public health emergency, FDA has recommended the use of patient-reported outcome (PRO) instruments to assess COVID-19 symptoms measured from a patient perspective.

Doctors need to conduct PRO assessments of COVID-19 symptoms every 24 hours and the assessments should be at the same time each day. The adoption of electronic data collection systems with reminders to trial subjects to complete the PRO instrument can minimize missing data and provide time stamps of completion. Alternatively, if a paper-based diary is used, sponsors should send reminders via phone calls, text messages, email to the trial subjects.  

According to Dr TR Chandrashekar, consultant, Institute of Gastroenterology Sciences and Organ Transplant (IGOT), Victoria Hospital, the FDA has issued these guidelines for the drug studies to monitor the symptoms of COVID-19 and have a estimation of correction of those manifestations by the said drug.  The guideline also includes the way the results should be interpreted. All these are said to have standard format across all studies done so that they can be compared and to generate meaning full results.

Given the heterogeneous nature of COVID-19 among outpatients, key symptoms should be assessed systematically to provide an accurate evaluation. The regulatory has indicated a set of 14 common corona virus related symptoms covering runny nose, sore throat, difficulty in breathing, cough, tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea and diarrhoea.

“Depending on the COVID-19 symptoms, the patient is given a score .The score depends on cough, fever, throat pain, diarrhoea, vomiting, loss of smell and breathlessness. These patients have to be enrolled in the study and based on the symptomatic relief they can exit the trials. There is a start point and en- point of 2 to 3 weeks which is an appropriate duration. Since this is a new disease, a proper trial has to be done as there are no specific drugs. In case we have to give prophylaxis, it will depend on symptomatic patients versus patients with no symptoms,” said Dr Vidya V Bhat, medical director, RadhaKrishna Multispecialty Hospital, Bengaluru.