Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers
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|ClinicalTrials.gov Identifier: NCT04438837|
Recruitment Status : Unknown
Verified July 2020 by Nesrin Ghanem-Zoubi MD, Rambam Health Care Campus.
Recruitment status was: Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : July 23, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Disease 2019 (COVID-19) Post-Exposure Prophylaxis||Drug: Hydroxychloroquine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||582 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers: A Randomized-Controlled Trial|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
No Intervention: control group
Active Comparator: intervention group
participants will recieve hydroxychloroquine in a dosage regimen of 400mg BID in the first day followed by 200mg BID for overall 10 days.
Hydroxychloroquine post exposure prohylaxis
Other Name: Plaquenil
- Clinical COVID-19 [ Time Frame: 14 days following exposure. ]Number of patients developing clinical symptoms and signs compatible with COVID-19 following exposure
- Confirmed COVID-19 [ Time Frame: 14 days following exposure. ]PCR- proven COVID-19 (confirmed cases)
- Time to virological recovery [ Time Frame: 30 days ]Time to virological recovery for participants who develop confirmed COVID-19
- Time to symptoms onset [ Time Frame: 14 days ]Time to symptoms onset defined as days until start of fever, cough or shortness of breath.
- Development of pneumonia [ Time Frame: 14 days ]Development of pneumonia- clinical and radiological (chest X ray or CT).
- Development of severe disease [ Time Frame: 14 days ]Development of severe disease- respiratory failure, mechanical ventilation, severe sepsis, multi-organ failure or acute myocarditis)
- Need for hospitalization or ICU [ Time Frame: 14 days ]Need for hospitalization, need for ICU admission
- Adverse events [ Time Frame: 14 days ]Number of adverse events - prolonged QT, arrhythmias, nausea, vomiting
- Mortality [ Time Frame: 30 days ]All-cause mortality at the end of follow up
- Time to de-isolation [ Time Frame: 30 days ]Number of days between exposure to de-isolation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438837
|Contact: Nesrin Ghanem-Zoubi, MDfirstname.lastname@example.org|
|Rambam Health Care Campus|
|Contact: Nesrin Ghanem-Zoubi email@example.com|
|Principal Investigator: Nesrin Ghanem-Zoubi|
|Study Chair:||Mical Paul, MD||Rambam|