The NIH reported Saturday that it has stopped a clinical trial evaluating the safety and effectiveness of hydroxychloroquine as a treatment of adults hospitalized with COVID-19. The decision followed a recommendation late Friday by the data and safety monitoring board, which determined that use of the drug caused no harm but it was unlikely to show benefit compared with placebo. The ORCHID study was being conducted by the Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network at the NIH’s National Heart, Lung and Blood Institute. When it was stopped, the blinded, placebo-controlled, randomized trial had enrolled more than 470 adults – about 30 shy of the enrollment goal. Participants will continue to receive standard of care and follow-up as indicated for their condition, according to the NIH.
With dexamethasone the latest drug to show promise in treating people hospitalized with severe cases of COVID-19, at least one of the companies manufacturing the generic steroid is having trouble keeping up with the increased demand for the drug. In updating its drug shortage list late last week, the FDA noted that supplies of the drug from East Windsor, N.J.-based Auromedics Pharma LLC, formerly Aurobindo Pharma Ltd., are on backorder. The next shipment of the company’s 120-mg/30 mL version isn’t expected until August and the 20-mg/5 mL version is on backorder until September. Somerset Therapeutics LLC, of Somerset, N.J., reported Monday that it has the drug in stock but there is a capacity constraint. Other companies making dexamethasone have recently confirmed that while the steroid is currently in stock, they are experiencing increased demand. Dexamethasone was first posted on the shortage list in February 2019, about a year before the pandemic hit the U.S. Now, word of its benefit in treating severe COVID-19 cases is adding to the demand. Last week, chief investigators for the U.K. RECOVERY trial, which tested dexamethasone in the most seriously ill patients, said the steroid should become standard of care after trial results showed a one-third reduction in deaths in patients on ventilators and a 15% reduction in 28-day mortality in patients receiving oxygen therapy.
Drug manufacturers should evaluate whether SARS-CoV-2 poses contamination risks under their existing manufacturing controls that prevent drug contamination and whether the coronavirus could adversely impact drug safety or quality if contamination did occur, the FDA said in a new guidance “Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological manufacturing.” In the U.S., drug manufacturing workers are deemed essential critical infrastructure workers during the pandemic. However, drug manufacturers should review the guidance for recommendations on restricting sick employees from production areas and assessing the risk to specific drugs, the facility, processes and manufacturing controls, the FDA said. The guidance also advises on procedures to minimize exposure and transmission of COVID-19 in the workplace, and it provides recommendations for maintaining the drug supply during the public health emergency.