Generics
Rising Pharmaceuticals to Support Phase 2 Clinical Trial of Chloroquine Phosphate for Prophylaxis Against COVID-19 in Healthcare Workers at Risk for COVID-19
21 May 2020 - - US-based pharmaceutical company Rising Pharma Holdings Inc will support a Phase 2 clinical trial designed to determine the clinical efficacy of chloroquine phosphate in preventing coronavirus disease 2019 (COVID-19) in healthcare workers with moderate to high risk of exposure to SARS-CoV-2, the virus that causes COVID-19, the company said.

Researchers at Columbia University are conducting this critical study to assess CQ as prophylaxis against COVID-19 in healthcare workers.

A 100-patient study conducted in China found that CQ was superior to control treatment in patients with COVID-19 pneumonia, with no serious adverse events reported, and preliminary in vitro data suggest that it may also block SARS-CoV-2 infection.

The randomised, double blind, placebo-controlled Phase 2 trial will enroll 350 volunteers who work in direct patient care roles at Columbia University Irving Medical Center and who have contact with patients who may have COVID-19 infection.

Participants will be stratified based on exposure risk, with moderate risk defined as patient-facing work in outpatient/in-house clinic at least two days per week and high risk defined as work performed in an intensive care unit, emergency room, or procedure room that contains aerosolized particles and high risk of contamination.

Subjects will also be stratified by age (younger or older than 50 years of age). Subjects will receive 500 mg of orally administered CQ daily for one week and then 500 mg weekly for the duration of COVID-19 exposure.

The primary endpoint is a 67% decrease in the number of at-risk health workers with symptomatic COVID-19 between the CQ and control arms (a decrease in expected infections from 15% in the control arm to 5% in the CQ arm).

The secondary endpoints are a 67% decrease in the number of at-risk healthcare workers who develop antibodies against SARS-COV-2 (a measure of infection) between the CQ and control arms, the percent of patients with adverse events Grade 3 or higher, and the % of patients with gastrointestinal intolerance to CQ.

Chloroquine Phosphate tablets are indicated for the: treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P. malariae, P. ovale, and P. vivax; prophylaxis of malaria in geographic areas where chloroquine resistance is not present; and treatment of existential amebiasis.

Rising Pharma Holdings, Inc., a privately held company, sells generic prescription products and over-the-counter pharmaceutical products under the Rising label to leading wholesalers, chain drug stores, distributors, and mass merchandisers.

The company continually seeks new opportunities to develop its business through strategic partnerships with manufacturers, marketers, and distributors under the Rising label.
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