Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women

NCT04354441 | Withdrawn Phase 2 DMC

• 1 other identifier: 1, March 30, 2020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

COVID-19 was declared a pandemic on March 11th. Efforts to save lives are essential as we will face increasing morbidity with rising demands on health care resources. Since pregnant women with COVID-19 have systematically been excluded from drug trials, potential treatment options for these high-risk individuals remain untested. The aim of our trial is to determine whether hydroxychloroquine given to COVID-19 positive pregnant women can reduce COVID-19-related hospital admissions, thereby allowing women to stay at home while limiting utilization of hospital resources and resulting exposure of health care providers.

Conditions

COVID-19; SARS-CoV-2; Pregnant Women; Hydroxychloroquine

Keywords

COVID-19; SARS-CoV-2; Pregnancy; hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• COVID-19-related hospital admissions

  COVID-19-related hospital admissions will be reported by the participants throughout pregnancy until delivery.

  Hospital Admission at any point from study enrollment to delivery

Secondary Outcomes (14)

• Symptoms related to COVID-19 infection

  Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery

• Adverse Events

  Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery

• Maternal outcomes

  Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.

• Maternal outcomes

  Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.

• Maternal outcomes

  Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.

Study Arms (2)

hydroxychloroquine

EXPERIMENTAL

10-day course of hydroxychloroquine 200 mg tablet twice a day. To be taken orally.

Drug: hydroxychloroquine sulfate 200 MG

Placebo

PLACEBO COMPARATOR

An identical appearing placebo. To be taken orally twice a day for 10-days.

Drug: Placebo oral tablet

Interventions

hydroxychloroquine sulfate 200 MG DRUG

Hydroxychloroquine sulfate (Plaquenil) 2MG will be taken twice a day for 10 days. Participants will be couriered the medication upon giving consent and will start taking the medication immediately.

hydroxychloroquine

Placebo oral tablet DRUG

Placebo that is identical in appearance to the study medication will be taken twice a day for 10 days. It will be couriered to participants upon giving consent. They will start taking the medication immediately.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a self-reported live pregnancy \>14 weeks
• Presently in the outpatient setting (i.e. not admitted to the hospital)
• Tested positive for COVID-19 within last 7 days
• Must be living in Canada

You may not qualify if:

• Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Known cardiac disease (or under investigation)
• Currently taking medication contraindicated as per Health Canada list for hydroxychloroquine
• Known retinopathy
• Known hypersensitivity to 4-aminoquinoline compounds
• Already taking hydroxychloroquine
• Unwilling to answer follow-up questionnaires
• Currently in labor
• Inpatient women at time of COVID-19 diagnosis.

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Related Publications (11)

• Lapinsky SE. Management of Acute Respiratory Failure in Pregnancy. Semin Respir Crit Care Med. 2017 Apr;38(2):201-207. doi: 10.1055/s-0037-1600909. Epub 2017 May 22.

  PMID: 28561251 BACKGROUND

• Callaghan WM, Creanga AA, Jamieson DJ. Pregnancy-Related Mortality Resulting From Influenza in the United States During the 2009-2010 Pandemic. Obstet Gynecol. 2015 Sep;126(3):486-490. doi: 10.1097/AOG.0000000000000996.

  PMID: 26244541 BACKGROUND

• Mor G, Cardenas I. The immune system in pregnancy: a unique complexity. Am J Reprod Immunol. 2010 Jun;63(6):425-33. doi: 10.1111/j.1600-0897.2010.00836.x. Epub 2010 Mar 29.

  PMID: 20367629 BACKGROUND

• Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12.

  PMID: 32151335 BACKGROUND

• Liu Y, Chen H, Tang K, Guo Y. Withdrawn: Clinical manifestations and outcome of SARS-CoV-2 infection during pregnancy. J Infect. 2020 Mar 5:S0163-4453(20)30109-2. doi: 10.1016/j.jinf.2020.02.028. Online ahead of print.

  PMID: 32145216 BACKGROUND

• Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. No abstract available.

  PMID: 32194981 BACKGROUND

• Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li H, Tan W, Liu D. In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Jul 28;71(15):732-739. doi: 10.1093/cid/ciaa237.

  PMID: 32150618 BACKGROUND

• Andreoli L, Bertsias GK, Agmon-Levin N, Brown S, Cervera R, Costedoat-Chalumeau N, Doria A, Fischer-Betz R, Forger F, Moraes-Fontes MF, Khamashta M, King J, Lojacono A, Marchiori F, Meroni PL, Mosca M, Motta M, Ostensen M, Pamfil C, Raio L, Schneider M, Svenungsson E, Tektonidou M, Yavuz S, Boumpas D, Tincani A. EULAR recommendations for women's health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome. Ann Rheum Dis. 2017 Mar;76(3):476-485. doi: 10.1136/annrheumdis-2016-209770. Epub 2016 Jul 25.

  PMID: 27457513 BACKGROUND

• Izmirly PM, Costedoat-Chalumeau N, Pisoni CN, Khamashta MA, Kim MY, Saxena A, Friedman D, Llanos C, Piette JC, Buyon JP. Maternal use of hydroxychloroquine is associated with a reduced risk of recurrent anti-SSA/Ro-antibody-associated cardiac manifestations of neonatal lupus. Circulation. 2012 Jul 3;126(1):76-82. doi: 10.1161/CIRCULATIONAHA.111.089268. Epub 2012 May 24.

  PMID: 22626746 BACKGROUND

• Costedoat-Chalumeau N, Amoura Z, Duhaut P, Huong DL, Sebbough D, Wechsler B, Vauthier D, Denjoy I, Lupoglazoff JM, Piette JC. Safety of hydroxychloroquine in pregnant patients with connective tissue diseases: a study of one hundred thirty-three cases compared with a control group. Arthritis Rheum. 2003 Nov;48(11):3207-11. doi: 10.1002/art.11304.

  PMID: 14613284 BACKGROUND

• Costedoat-Chalumeau N, Amoura Z, Huong DL, Lechat P, Piette JC. Safety of hydroxychloroquine in pregnant patients with connective tissue diseases. Review of the literature. Autoimmun Rev. 2005 Feb;4(2):111-5. doi: 10.1016/j.autrev.2004.11.009. Epub 2004 Dec 14.

  PMID: 15722258 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician & gynecologist; Director of Perinatal Research

Model Details: Participants will be randomized 1:1 to receive either the study medication (hydroxychloroquine) or an identical-looking placebo. Randomization will be in blocks of 4-6, stratified by province.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 21, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06