COVID-19Phase 2HyPreCNCT04354441
Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women
A Phase 2 study testing hydroxychloroquine sulfate 200 MG in people with COVID-19 and SARS-CoV-2, run by Sir Mortimer B. Davis - Jewish General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- COVID-19, SARS-CoV-2, Pregnant Women
- What is being tested?
- hydroxychloroquine sulfate 200 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2020to May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Unwilling to answer follow-up questionnaires
- Currently in labor
- Inpatient women at time of COVID-19 diagnosis.
About this study
Official title: Randomized Trial Evaluating Effect of Outpatient Hydroxychloroquine on Reducing Hospital Admissions in Pregnant Women With SARS-CoV-2 Infection: HyPreC Trial
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.
Read the detailed description
Due to physiologic and immune changes, pregnant women are at high risk of severe complications and mortality from COVID-19 infections. Despite this, epidemiologic data on SARS-CoV-2 infection in pregnancy is currently limited to small case-series describing a clinical course ranging from mild to critical illness requiring extracorporeal membrane oxygenation. Chloroquine and hydroxychloroquine (HCQ) have demonstrated activity against SARS-coronaviruses in laboratory studies and are being tested in COVID-19 positive patients. HCQ appears more promising than chloroquine due to its greater effectiveness against SARS-CoV-2 in vitro and better safety profile. To date, pregnant women have been systematically excluded from trials conducted in the general outpatient population. Thus, we will carry out a randomized, placebo-controlled, double blinded trial of HCQ (considered safe in pregnancy in pregnant women with early COVID-19 infection across Canada to evaluate its effect in reducing COVID-19-related hospitalizations. This outpatient intervention is of paramount importance as its goal is to avoid overloading emergency rooms, obstetric triage, inpatient wards and critical care units. Upon completion of 6-month, our results can be directly applied to clinical care.
- Conditions
- COVID-19, SARS-CoV-2, Pregnant Women, Hydroxychloroquine
- Being tested
- hydroxychloroquine sulfate 200 MG, Placebo oral tablet
- Keywords
- COVID-19, SARS-CoV-2, Pregnancy, hydroxychloroquine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxychloroquine sulfate 200 MGDrug
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.
Placebo oral tabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| hydroxychloroquine | Experimental | 10-day course of hydroxychloroquine 200 mg tablet twice a day. To be taken orally. Receives: Drug: hydroxychloroquine sulfate 200 MG |
| Placebo | Placebo comparator | An identical appearing placebo. To be taken orally twice a day for 10-days. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19-related hospital admissions
COVID-19-related hospital admissions will be reported by the participants throughout pregnancy until delivery.
Measured: Hospital Admission at any point from study enrollment to delivery
Secondary outcomes (14)
Symptoms related to COVID-19 infection
Measurement of reported symptoms using a validated questionnaire on Day 3, 7, 10, and every 2 weeks. The FLU-PRO Questionnaire instructs respondents to rate the severity of 37 influenza symptoms over the past 24 hours, including those related to the nose, throat, eye, chest, head, stomach, fatigue, and body aches/pains. For 32 of 37 items, respondents rated the severity of each symptom on 5-point Likert-type scales from 0 ("Not at all), 1 ("A little bit"), 2 ("Somewhat"), 3 ("Quite a bit"), to 4 ("Very much"). For the five remaining items, severity is expressed as frequency of occurrence: vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times), and sneezing, coughing, and coughed up mucus or phlegm on a scale from 0 ("Never") to 4 ("Always"), with higher scores indicating more severe symptoms.
Measured: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
Adverse Events
Side effects related to hydroxychloqoruine
Measured: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
Maternal outcomes
Type of delivery (elective non-urgent cesarean, elective urgent cesarean section, non-elective cesarean within labor, instrumental vaginal, spontaneous vaginal)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Maternal outcomes
If had cesarean delivery, indication for cesarean section
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Maternal outcomes
Miscarriage or stillbirth (Yes/No)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Maternal outcomes
Labor induction or augmentation (Yes/No) and indication
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Maternal outcomes
Epidural use (Yes/No)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Newborn outcomes
Gestational age at delivery (weeks)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Sex (female/male)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Birth weight (kg)
Birth weight (kg)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Need for resuscitation (Yes/No)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
NICU admission (Yes/No)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Medical conditions (jaundice, IVH, RDS, pneumothorax, PDA, NEC)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Current disposition of baby (home or hospital)
Measured: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study startMay 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: Not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haim Abenhaim, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354441
- Sponsor's protocol ID
- 1, March 30, 2020
- Acronym
- HyPreC
- Status last verified
- Jun 2020
- First submitted
- 14 Apr 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28561251Callaghan 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.
PubMed 26244541Mor 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.
PubMed 20367629Chen 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.
PubMed 32151335Liu 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.
PubMed 32145216Liu 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.
PubMed 32194981Yao 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.
PubMed 32150618Andreoli 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.
PubMed 27457513Izmirly 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.
PubMed 22626746Costedoat-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.
PubMed 14613284Costedoat-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.
PubMed 15722258
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Evaluating Effect of Outpatient Hydroxychloroquine on Reducing Hospital Admissions in Pregnant Women With SARS-CoV-2 Infection: HyPreC Trial
- ClinicalTrials.gov ID
- NCT04354441
- Acronym / sponsor ID
- HyPreC / 1, March 30, 2020
- Conditions
- COVID-19, SARS-CoV-2, Pregnant Women, Hydroxychloroquine
- Keywords
- COVID-19, SARS-CoV-2, Pregnancy, hydroxychloroquine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Due to physiologic and immune changes, pregnant women are at high risk of severe complications and mortality from COVID-19 infections. Despite this, epidemiologic data on SARS-CoV-2 infection in pregnancy is currently limited to small case-series describing a clinical course ranging from mild to critical illness requiring extracorporeal membrane oxygenation. Chloroquine and hydroxychloroquine (HCQ) have demonstrated activity against SARS-coronaviruses in laboratory studies and are being tested in COVID-19 positive patients. HCQ appears more promising than chloroquine due to its greater effectiveness against SARS-CoV-2 in vitro and better safety profile. To date, pregnant women have been systematically excluded from trials conducted in the general outpatient population. Thus, we will carry out a randomized, placebo-controlled, double blinded trial of HCQ (considered safe in pregnancy in pregnant women with early COVID-19 infection across Canada to evaluate its effect in reducing COVID-19-related hospitalizations. This outpatient intervention is of paramount importance as its goal is to avoid overloading emergency rooms, obstetric triage, inpatient wards and critical care units. Upon completion of 6-month, our results can be directly applied to clinical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| hydroxychloroquine | Experimental | Drug: hydroxychloroquine sulfate 200 MG10-day course of hydroxychloroquine 200 mg tablet twice a day. To be taken orally. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletAn identical appearing placebo. To be taken orally twice a day for 10-days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxychloroquine sulfate 200 MGHydroxychloroquine 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. | Drug | hydroxychloroquine |
| Placebo oral tabletPlacebo 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. | Drug | Placebo |
Primary outcome
COVID-19-related hospital admissions
Time frame: Hospital Admission at any point from study enrollment to delivery
COVID-19-related hospital admissions will be reported by the participants throughout pregnancy until delivery.
14 secondary outcomes
Symptoms related to COVID-19 infection
Time frame: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
Adverse Events
Time frame: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery
Maternal outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Maternal outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Maternal outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Maternal outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Maternal outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.
Newborn outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Newborn outcomes
Time frame: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Background: PubMed 28561251Lapinsky 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.
- Background: PubMed 26244541Callaghan 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.
- Background: PubMed 20367629Mor 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.
- Background: PubMed 32151335Chen 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.
- Background: PubMed 32145216Liu 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.
- Background: PubMed 32194981Liu 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.
- Background: PubMed 32150618Yao 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.
- Background: PubMed 27457513Andreoli 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.
- Background: PubMed 22626746Izmirly 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.
- Background: PubMed 14613284Costedoat-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.
- Background: PubMed 15722258Costedoat-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hydroxychloroquine sulfate 200 MG in people with COVID-19 and SARS-CoV-2, run by Sir Mortimer B. Davis - Jewish General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19-related hospital admissions (time frame: Hospital Admission at any point from study enrollment to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04354441, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.