Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers
Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Background: The rapid spread and high infectivity of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV2) makes identifying an effective prophylaxis agent highly important.
One of the important target populations for such intervention who are at high risk of
exposure are health care workers (HCWs) who may develop disease and/or expose patients and
other HCWs. Hydroxychloroquine (HCQ), currently in usage for treatment of severe Coronavirus
Disease 2019 (COVID-19), has in addition to in-vitro activities of inhibition of virus
replication and immunomodulation, an important role in the inhibition of pre-entry step of
the virus to host cells. Such activity in the early stage of infection may play a role in
prevention of disease progression.
Objectives: To evaluate the effect of HCQ in prevention of clinical disease and reduction of
viral shedding among HCWs following exposure to confirmed COVID-19 patients.
Study design: Multi-center, randomized controlled, superiority, open label trial Setting: The
study will be conducted at Rambam Health Care Campus. Eligibility: Participants eligible for
inclusion will include non-pregnant adult (>18 years old) HCWs who were exposed to a
confirmed case of COVID-19 without full adherence to droplet precautions. Participants will
be eligible in a period no longer than 72 hours after exposure.
Intervention: HCQ will be given in the intervention group in a dosage regimen of 400mg BID in
the first day followed by 200mg BID for overall 10 days. Participants in the control group
will receive no treatment. Treatment will be started no longer than 72 hours following
exposure.
Outcomes: The primary outcome will be the number of participants who develop clinical signs
compatible with COVID 19 (defined in full protocol) within 14 days of exposure. Secondary
outcomes will include virologically-confirmed COVID 19, disease severity (need for
hospitalization, mechanical ventilation and 30-day mortality) and viral shedding duration
(time between first positive PCR to last of two consecutive negative tests) for confirmed
COVID 19 cases.
Sample size: The trial will test for HCQ's superiority assuming a primary outcome incidence
of 20% in the control group and a reduction of 50% with HCQ. The sample size required for a
power of 80% (alpha 0.05) is 291 participants per each group.