Table 2.
COVID-19-Related Clinical Trials Reporting Inclusion of Pregnant or Breastfeeding Women
| NCT Number | Location | Study Name | Recruitment Number | Medication/Therapy Under Investigation |
|---|---|---|---|---|
| Convalescent plasma | ||||
| NCT04411602 | United States | Feasibility Study of Anti-SARS-CoV-2 Plasma Transfusions in COVID-19 Patients With SRD | 90 | |
| NCT04342182 | Netherlands | Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study) | 426 | |
| NCT04345523 | Spain | Convalescent Plasma Therapy vs. SOC for the Treatment of COVID19 in Hospitalized Patients | 278 | |
| NCT04347681 | Saudi Arabia | Potential Efficacy of Convalescent Plasma to Treat Severe COVID-19 and Patients at High Risk of Developing Severe COVID-19 | 40 | |
| NCT04348656 | United States, Canada | CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1) | 1200 | |
| NCT04361253 | United States | Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy | 220 | |
| NCT04373460 | United States | Convalescent Plasma to Limit SARS-CoV-2 Associated Complications | 1344 | |
| NCT04385199 | United States | Convalescent Plasma for Patients With COVID-19 | 30 | |
| NCT04405310 | Mexico | Convalescent Plasma of Covid-19 to Treat SARS-COV-2 a Randomized Double Blind 2 Center Trial | 80 | |
| NCT04412486 | United States | COVID-19 Convalescent Plasma (CCP) Transfusion | 100 | |
| NCT04356482 | Mexico | Convalescent Plasma for Ill Patients by COVID-19 | 90 | |
| NCT04376034 | United States | Convalescent Plasma Collection and Treatment in Pediatrics and Adults | 240 | |
| NCT04388527 | United States | COVID-19 Convalescent Plasma for Mechanically Ventilated Population | 50 | |
| NCT04392232 | United States | A Study of COVID 19 Convalescent Plasma in High Risk Patients With COVID 19 Infection | 100 | |
| NCT04397757 | United States | COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2 | 80 | |
| NCT04421404 | United States | Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients | 30 | |
| NCT04364737 | United States | Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients | 300 | |
| NCT04381858 | Mexico | Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia | 500 | Convalescent plasma vs human immunoglobulin |
| Hydroxychloroquine/chloroquinea | ||||
| NCT04308668 | United States | Post-exposure Prophylaxis/Preemptive Therapy for SARS-Coronavirus-2 | 3000 | Hydroxychloroquine |
| NCT04328467 | United States | Pre-exposure Prophylaxis for SARS-Coronavirus-2 | 3500 | Hydroxychloroquine |
| NCT04323527 | Brazil | Chloroquine Diphosphate for the Treatment of Severe Acute Respiratory Syndrome Secondary to SARS-CoV2 | 440 | Chloroquine diphosphate |
| NCT04328493 | Vietnam | The Vietnam Chloroquine Treatment on COVID-19 | 250 | Chloroquine |
| NCT04328961 | United States | Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP) | 2000 | Hydroxychloroquine |
| NCT04334148 | United States | Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine | 15000 | Hydroxychloroquine |
| NCT04335552 | United States | Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection | 500 | Hydroxychloroquine, azithromycin |
| NCT04350281 | Hong Kong | Double Therapy With IFN-beta 1b and Hydroxychloroquine | 80 | Hydroxychloroquine, IFN-beta 1b |
| NCT04342169 | United States | University of Utah COVID-19 Hydroxychloroquine Trial | 400 | Hydroxychloroquine |
| NCT04352933 | United Kingdom | PROLIFIC Chemoprophylaxis Trial (COVID-19) | 1000 | Hydroxychloroquine |
| NCT04354428 | United States | Treatment for COVID-19 in High-Risk Adult Outpatients | 630 | Hydroxychloroquine, azithromycin |
| NCT04363450 | United States | Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP) | 1700 | Hydroxychloroquine |
| NCT04364022 | Switzerland | Efficacy of Pragmatic Same-day COVID-19 Ring Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland | 420 | Hydroxychloroquine, lopinavir/ritonavir |
| NCT04435808 | United States | Efficacy of Hydroxychloroquine Prophylaxis for Health Care Workers at High Risk for COVID-19 | 350 | Hydroxychloroquine |
| NCT04410562 | Spain | Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy | 714 | Hydroxychloroquine |
| Biologics | ||||
| NCT04327388 | Canada | Sarilumab COVID-19 | 300 | Sarilumab SAR153191 |
| NCT04317092 | Italy | Tocilizumab in COVID-19 Pneumonia (TOCIVID-19) | 400 | Tocilizumab injection |
| Antivirals | ||||
| NCT04292899b | United States | Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Severe Coronavirus Disease (COVID-19) | 2400 | Remdesivir |
| NCT04292730b | United States | Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment | 1600 | Remdesivir |
| Other/multidrug combination | ||||
| NCT02735707c | Australia | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia | 6800 | Various drug treatments |
| NCT04381936 | United Kingdom | Randomised Evaluation of COVID-19 Therapy | 12000 | Various drug treatments |
| NCT04342689 | United States | The Role of Resistant Starch in COVID-19 Infection | 1500 | Dietary supplement |
| NCT04374461 | United States | A Study of N-acetylcysteine in Patients With COVID-19 Infection | 86 | N-acetylcysteine |
| NCT04366960 | Italy | Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients | 2712 | Enoxaparin |
| NCT04367831 | United States | Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19 | 100 | Enoxaparin, heparin |
| NCT0430824d | United States | Covid-19 Associated Coagulopathy | 170 | Intermediate-dose thromboprophylaxis |
| NCT04381962 | United Kingdom | A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2) | 800 | Azithromycin |
| NCT04319731 | United States | A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure | 10 | Human amniotic fluid |
| NCT04444271 | Pakistan | Mesenchymal Stem Cell Infusion for COVID-19 Infection | 20 | Mesenchymal stem cells |
aOne study (NCT04408456) reported that pregnant or breastfeeding persons would be included in the control arm only (not displayed here).
bCompassionate use basis only.
cPregnant or breastfeeding women are excluded from particular study arms.
dPregnancy is an exclusion criterion; breastfeeding is not.