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Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.
Skipper, Caleb P; Pastick, Katelyn A; Engen, Nicole W; Bangdiwala, Ananta S; Abassi, Mahsa; Lofgren, Sarah M; Williams, Darlisha A; Okafor, Elizabeth C; Pullen, Matthew F; Nicol, Melanie R; Nascene, Alanna A; Hullsiek, Kathy H; Cheng, Matthew P; Luke, Darlette; Lother, Sylvain A; MacKenzie, Lauren J; Drobot, Glen; Kelly, Lauren E; Schwartz, Ilan S; Zarychanski, Ryan; McDonald, Emily G; Lee, Todd C; Rajasingham, Radha; Boulware, David R.
  • Skipper CP; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Pastick KA; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Engen NW; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Bangdiwala AS; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Abassi M; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Lofgren SM; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Williams DA; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Okafor EC; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Pullen MF; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Nicol MR; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Nascene AA; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Hullsiek KH; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Cheng MP; Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).
  • Luke D; M Health Fairview Investigational Drug Service Pharmacy, Minneapolis, Minnesota (D.L.).
  • Lother SA; University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).
  • MacKenzie LJ; University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).
  • Drobot G; University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).
  • Kelly LE; George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada (L.E.K.).
  • Schwartz IS; University of Alberta, Edmonton, Alberta, Canada (I.S.S.).
  • Zarychanski R; University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).
  • McDonald EG; Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).
  • Lee TC; Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).
  • Rajasingham R; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
  • Boulware DR; University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).
Ann Intern Med ; 173(8): 623-631, 2020 10 20.
Article in English | MEDLINE | ID: covidwho-981646
Semantic information from SemMedBD (by NLM)
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hydroxychloroquine
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TREATS
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hydroxychloroquine
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4. hydroxychloroquine PREVENTS COVID-19
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5. COVID-19 PROCESS_OF Outpatients
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6. Laboratory Infection PROCESS_OF Persons
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Laboratory Infection
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7. hydroxychloroquine ADMINISTERED_TO Participant
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hydroxychloroquine
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hydroxychloroquine
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COVID-19
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12. hydroxychloroquine PREVENTS COVID-19
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hydroxychloroquine
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ABSTRACT

BACKGROUND:

No effective oral therapy exists for early coronavirus disease 2019 (COVID-19).

OBJECTIVE:

To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.

DESIGN:

Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov NCT04308668).

SETTING:

Internet-based trial across the United States and Canada (40 states and 3 provinces).

PARTICIPANTS:

Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset. INTERVENTION Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo. MEASUREMENTS Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.

RESULTS:

Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point]; P = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo (P = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo (P < 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death (P = 0.29).

LIMITATION:

Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.

CONCLUSION:

Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19. PRIMARY FUNDING SOURCE Private donors.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Outpatients / Pneumonia, Viral / Coronavirus Infections / Pandemics / Betacoronavirus / Hydroxychloroquine Type of study: Controlled clinical trial / Etiology study / Observational study / Prognostic study / Randomized controlled trials / Risk factors Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Ann Intern Med Year: 2020 Document Type: Article

Full text: Available Collection: International databases Database: MEDLINE Main subject: Outpatients / Pneumonia, Viral / Coronavirus Infections / Pandemics / Betacoronavirus / Hydroxychloroquine Type of study: Controlled clinical trial / Etiology study / Observational study / Prognostic study / Randomized controlled trials / Risk factors Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Ann Intern Med Year: 2020 Document Type: Article