Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
3 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-04-17
Study Completion Date
2020-07-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by PCR) , 7 days after initiation of therapy compared to control patients receiving placebo.
The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.
The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hydroxychloroquine in Outpatient Adults With COVID-19
NCT04333654
Coronavirus Infection
TERMINATED
PHASE1
Hydroxychloroquine Versus Placebo in COVID-19 Patients at Risk for Severe Disease
NCT04325893
Coronavirus
TERMINATED
PHASE3
A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
NCT04345692
COVID-19
TERMINATED
PHASE3
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
NCT04429867
COVID-19
UNKNOWN
PHASE4
Hydroxychloroquine for the Treatment of Mild COVID-19 Disease
NCT04340544
COVID-19
TERMINATED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hydroxychloroquine (HCQ), which is a less toxic derivative of chloroquine (CQ), has been shown to be effective in inhibiting Covid-19 infection in vitro. The evidence from clinical research trials is sparse and has many flaws. Much of the Chinese experience with Chloroquine comes from a letter to the editor and a news briefing/conference held on February 15, 2020. The letter describes experience with more than 100 patients treated with CQ in multicenter clinical trials but the letter provides no quantitative data to back their claims. At least one non-randomized clinical trial has been performed in Europe. Covid-19 infected patients received 10 days of HCQ daily and underwent daily testing of viral loads from nasopharyngeal swabs. The subjects receiving HCQ were much more likely (P\<0.02) to clear their viral load than subjects who did not receive HCQ. The study had many flaws, which make the conclusions less valuable than rigorously designed randomized clinical trial. This study is designed as a randomized, blinded trial to either confirm or refute the efficacy of HCQ in early treatment of Covid19 infection to ameliorate disease severity, and reduce viral load.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Covid 19
Corona Virus Infection
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized placebo verses medication clinical trial
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Blinded to subject and investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hydroxychloroquine
Subjects in this arm will receive the study drug
Group Type
EXPERIMENTAL
Hydroxychloroquine
Intervention Type
DRUG
Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days.
Placebo
Subjects in this arm will take placebo for 6 days
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hydroxychloroquine
Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days.
Intervention Type
DRUG
Placebo
Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
plaquenil
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Symptoms occurring within 3 days prior to patient presenting to USA Facility for PCR nasopharyngeal swab
* Nasopharyngeal swab positive for Covid-19 infection and/or exposure and/or symptoms congruent with fever and cough
* Male or Female age 19 to 89 years
* Able to take oral medications
* Patients not requiring hospitalization
* Provision of informed consent
* Nasopharyngeal swab positive for Covid-19 infection and/or exposure and/or symptoms congruent with fever and cough
* Male or Female age 19 to 89 years
* Able to take oral medications
* Patients not requiring hospitalization
* Provision of informed consent
Exclusion Criteria
* Known history of EKG QTc prolongation abnormality
* Contraindication or allergy to hydroxychloroquine
* Retinal eye disease
* Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
* Known chronic kidney disease, stage 4 or 5 or receiving dialysis
* Weight \< 40 kg
* Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)
* Known hepatic disease (cirrhosis, hepatitis)
* Active treatment for cancer (chemotherapy, radiation, surgery within 3 months
* On immunosuppressive drugs steroids, antirejection medications.
* Recipient of solid organ transplant
* Pregnancy/breastfeeding
* Past medical history Porphyria (may exacerbate disease)
* PMH Psoariasis (can worsen disease)
* No access to internet or email
* Current suicidal thoughts according to Columbia scale
* In the screening process before signing consent, subjects will be asked if they are suicidal. If this response is yes, patients will be excluded from trial and directed to the National Suicide Prevention Lifeline: 1-800-273-8255.
* Contraindication or allergy to hydroxychloroquine
* Retinal eye disease
* Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
* Known chronic kidney disease, stage 4 or 5 or receiving dialysis
* Weight \< 40 kg
* Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)
* Known hepatic disease (cirrhosis, hepatitis)
* Active treatment for cancer (chemotherapy, radiation, surgery within 3 months
* On immunosuppressive drugs steroids, antirejection medications.
* Recipient of solid organ transplant
* Pregnancy/breastfeeding
* Past medical history Porphyria (may exacerbate disease)
* PMH Psoariasis (can worsen disease)
* No access to internet or email
* Current suicidal thoughts according to Columbia scale
* In the screening process before signing consent, subjects will be asked if they are suicidal. If this response is yes, patients will be excluded from trial and directed to the National Suicide Prevention Lifeline: 1-800-273-8255.
Minimum Eligible Age
19 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of South Alabama
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
William Richards
Professor and Chair Surgery
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William O Richards, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Alabama College of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of South Alabama
Mobile, Alabama, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Percival I. Nuclear winter. Practitioner. 1988 Feb 8;232(1442):140-1. No abstract available.
Reference Type
BACKGROUND
Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.
Reference Type
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.
Reference Type
BACKGROUND
Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
Reference Type
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.
Reference Type
BACKGROUND
Sahraei Z, Shabani M, Shokouhi S, Saffaei A. Aminoquinolines against coronavirus disease 2019 (COVID-19): chloroquine or hydroxychloroquine. Int J Antimicrob Agents. 2020 Apr;55(4):105945. doi: 10.1016/j.ijantimicag.2020.105945. Epub 2020 Mar 17. No abstract available.
Reference Type
BACKGROUND
Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020 Apr;55(4):105932. doi: 10.1016/j.ijantimicag.2020.105932. Epub 2020 Mar 4. No abstract available.
Reference Type
BACKGROUND
Stokkermans TJ, Falkowitz DM, Trichonas G. Chloroquine and Hydroxychloroquine Toxicity. 2024 Jan 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537086/
Reference Type
BACKGROUND
Baden LR, Rubin EJ. Covid-19 - The Search for Effective Therapy. N Engl J Med. 2020 May 7;382(19):1851-1852. doi: 10.1056/NEJMe2005477. Epub 2020 Mar 18. No abstract available.
Reference Type
BACKGROUND
Zhou D, Dai SM, Tong Q. COVID-19: a recommendation to examine the effect of hydroxychloroquine in preventing infection and progression. J Antimicrob Chemother. 2020 Jul 1;75(7):1667-1670. doi: 10.1093/jac/dkaa114.
Reference Type
BACKGROUND
Chan KW, Wong VT, Tang SCW. COVID-19: An Update on the Epidemiological, Clinical, Preventive and Therapeutic Evidence and Guidelines of Integrative Chinese-Western Medicine for the Management of 2019 Novel Coronavirus Disease. Am J Chin Med. 2020;48(3):737-762. doi: 10.1142/S0192415X20500378. Epub 2020 Mar 13.
Reference Type
BACKGROUND
Dong L, Hu S, Gao J. Discovering drugs to treat coronavirus disease 2019 (COVID-19). Drug Discov Ther. 2020;14(1):58-60. doi: 10.5582/ddt.2020.01012.
Reference Type
BACKGROUND
Beigelman A, Bacharier LB, Baty J, Buller R, Mason S, Schechtman KB, Sajol G, Isaacson-Schmid M, Castro M, Storch GA. Does azithromycin modify viral load during severe respiratory syncytial virus bronchiolitis? J Allergy Clin Immunol. 2015 Oct;136(4):1129-31. doi: 10.1016/j.jaci.2015.06.011. Epub 2015 Jul 26. No abstract available.
Reference Type
BACKGROUND
Jiang S. Don't rush to deploy COVID-19 vaccines and drugs without sufficient safety guarantees. Nature. 2020 Mar;579(7799):321. doi: 10.1038/d41586-020-00751-9. No abstract available.
Reference Type
BACKGROUND
Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
Reference Type
BACKGROUND
Fedson DS, Opal SM, Rordam OM. Hiding in Plain Sight: an Approach to Treating Patients with Severe COVID-19 Infection. mBio. 2020 Mar 20;11(2):e00398-20. doi: 10.1128/mBio.00398-20.
Reference Type
BACKGROUND
Petri M, Elkhalifa M, Li J, Magder LS, Goldman DW. Hydroxychloroquine Blood Levels Predict Hydroxychloroquine Retinopathy. Arthritis Rheumatol. 2020 Mar;72(3):448-453. doi: 10.1002/art.41121. Epub 2020 Jan 7.
Reference Type
BACKGROUND
Sun ML, Yang JM, Sun YP, Su GH. [Inhibitors of RAS Might Be a Good Choice for the Therapy of COVID-19 Pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):219-222. doi: 10.3760/cma.j.issn.1001-0939.2020.03.016. Chinese.
Reference Type
BACKGROUND
Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2. No abstract available.
Reference Type
BACKGROUND
FitzGerald GA. Misguided drug advice for COVID-19. Science. 2020 Mar 27;367(6485):1434. doi: 10.1126/science.abb8034. Epub 2020 Mar 20. No abstract available.
Reference Type
BACKGROUND
Lotery A, Burdon M. Monitoring for hydroxychloroquine retinopathy. Eye (Lond). 2020 Aug;34(8):1301-1302. doi: 10.1038/s41433-020-0795-2. Epub 2020 Feb 13. No abstract available.
Reference Type
BACKGROUND
Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 May;55(5):105938. doi: 10.1016/j.ijantimicag.2020.105938. Epub 2020 Mar 12.
Reference Type
BACKGROUND
Sivakumar GK, Liu J, Sokoluk C, Ing EB. Online calculator for hydroxychloroquine dosing. Can J Ophthalmol. 2020 Aug;55(4):e148-e150. doi: 10.1016/j.jcjo.2020.01.002. Epub 2020 Feb 18. No abstract available.
Reference Type
BACKGROUND
Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.
Reference Type
BACKGROUND
Liu F, Xu A, Zhang Y, Xuan W, Yan T, Pan K, Yu W, Zhang J. Patients of COVID-19 may benefit from sustained Lopinavir-combined regimen and the increase of Eosinophil may predict the outcome of COVID-19 progression. Int J Infect Dis. 2020 Jun;95:183-191. doi: 10.1016/j.ijid.2020.03.013. Epub 2020 Mar 12.
Reference Type
BACKGROUND
Glauser W. Proposed protocol to keep COVID-19 out of hospitals. CMAJ. 2020 Mar 9;192(10):E264-E265. doi: 10.1503/cmaj.1095852. No abstract available.
Reference Type
BACKGROUND
Baron SA, Devaux C, Colson P, Raoult D, Rolain JM. Teicoplanin: an alternative drug for the treatment of COVID-19? Int J Antimicrob Agents. 2020 Apr;55(4):105944. doi: 10.1016/j.ijantimicag.2020.105944. Epub 2020 Mar 13.
Reference Type
BACKGROUND
Cunningham AC, Goh HP, Koh D. Treatment of COVID-19: old tricks for new challenges. Crit Care. 2020 Mar 16;24(1):91. doi: 10.1186/s13054-020-2818-6. No abstract available.
Reference Type
BACKGROUND
Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
[1582736-1]
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
NCT04361461
WITHDRAWN
PHASE3
PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine
NCT04353037
TERMINATED
PHASE2
Hydroxychloroquine for COVID-19
NCT04342221
TERMINATED
PHASE3
Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)
NCT04315896
COMPLETED
PHASE3
#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19
NCT04385264
WITHDRAWN
PHASE2/PHASE3
Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection
NCT04372017
TERMINATED
PHASE3
Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19)
NCT04466540
COMPLETED
PHASE4
University of Utah COVID-19 Hydrochloroquine Trial
NCT04342169
COMPLETED
PHASE2
Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care
NCT04334967
SUSPENDED
PHASE4
Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
NCT04590274
WITHDRAWN
PHASE1
A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19
NCT04379492
WITHDRAWN
PHASE2
Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease
NCT04358081
COMPLETED
PHASE3
Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19
NCT04348474
SUSPENDED
EARLY_PHASE1
Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients
NCT04522466
TERMINATED
PHASE3
Will Hydroxychloroquine Impede or Prevent COVID-19
NCT04341441
TERMINATED
PHASE3
Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers
NCT04333225
COMPLETED
PHASE2
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
NCT04358068
TERMINATED
PHASE2
Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk
NCT04371926
WITHDRAWN
NA
High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19
NCT04351620
COMPLETED
PHASE1
Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death
NCT04323631
WITHDRAWN
EARLY_PHASE1
Assessing Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19)
NCT04363866
WITHDRAWN
PHASE2
Hydroxychloroquine in COVID-19 Patients
NCT04394442
UNKNOWN
PHASE2
Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19
NCT04411433
UNKNOWN
PHASE3
EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA
NCT04347512
WITHDRAWN
PHASE3
Test and Treat COVID 65plus+
NCT04351516
WITHDRAWN
PHASE2/PHASE3