CoronavirusPhase 2NCT04353037
PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine
A Phase 2 study testing Group 1 HCQ in people with Coronavirus and Corona Virus Infection, run by UnitedHealth Group at 1 site in United States.
Trial summary
The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, Corona Virus Infection
- What is being tested?
- Group 1 HCQ
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2020to 11 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- Subjects meeting the following criteria by Sub-Study:
- Sub-Study 1: 50-75 years of age; self-reporting as having a fever within four days prior to time of enrollment; and not requiring hospitalization. Enrolled individuals will undergo testing for COVID-19 and sent home for self-quarantine.Participant must be willing and able to provide informed consent, agree to testing for COVID-19 at time of enrollment to confirm diagnosis and two weeks at the end of treatment.
- Sub-Study 2: Currently employed as a health care worker. Health care workers are defined as :
- Medical Doctor (MD)
- Doctor of Osteopathic Medicine (DO)
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- Nurse Practitioner (NP)
- Physician's Assistant (PA)
- Registered Nurse (RN)
- other members of the medical care team with significant COVID-19 exposure;
- Health care workers meeting the following criteria:
- asymptomatic and presumed negative for COVID-19 (no confirmatory testing conducted);
- scheduled for an average of >20 hours per week of clinical care over the next 2 months.
- Participant must agree to standard clinical guidelines and undergo COVID-19 testing upon the presentation of symptoms indicative of an influenza like illness; if a confirmatory COVID-19 diagnosis is given, participant will be offered to cross-over to HCQ 600 mg qd.
- Willing to report compliance with HCQ in the form of a diary and participate in other forms of self-reporting (e.g., symptom tracker and experience log).
- Subjects are willing and able to go to designated areas for testing of COVID-19/SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
- Participants must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
- Participants must have adequate baseline organ function
- Able to give informed consent
- Subjects meeting the following criteria by Sub-Study:
- Sub-Study 1: 50-75 years of age; self-reporting as having a fever within four days prior to time of enrollment; and not requiring hospitalization. Enrolled individuals will undergo testing for COVID-19 and sent home for self-quarantine. Participant must be willing and able to provide informed consent, agree to testing for COVID-19 at time of enrollment to confirm diagnosis and two weeks at the end of treatment.
- Sub-Study 2: Currently employed as a health care worker (Medical Doctor, MD; Doctor of Osteopathic Medicine, DO; Nurse Practitioner, NP; Physician's Assistant, PA; and Registered Nurse, RN or other members of the medical care team with significant COVID-19 exposure); asymptomatic and presumed negative for COVID-19 (no confirmatory testing conducted); scheduled for an average of >20 hours per week of clinical care over the next 2 months. Participant must agree to standard clinical guidelines and undergo COVID-19 testing upon the presentation of symptoms indicative of an influenza like illness; if a confirmatory COVID-19 diagnosis is given, participant will be offered to cross-over to HCQ 600 mg qd.
- Willing to report compliance with HCQ in the form of a diary and participate in other forms of self-reporting (e.g., symptom tracker and experience log).
- Subjects are willing and able to go to designated areas for testing of COVID-19/SARS-CoV-2.
- Participant must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
- Participant must have adequate baseline organ function
Who cannot join
- Allergy to hydroxychloroquine
- Pregnant or lactating or positive pregnancy test during pre-medication examination
- Receiving any trial treatment drug for 2019-ncov within 14 days prior to screening evaluation (off label, compassionate use or trial related).
- Known retinal disease including but not limited to macular degeneration, retinal vein occlusion, visual field defect, diabetic retinopathy
- History of interstitial lung disease or chronic pneumonitis unrelated COVID-19.
- Due to risk of disease exacerbation, participants with porphyria or psoriasis are ineligible unless the disease is well-controlled, and they are under the care of a specialist for the disorder who agrees to monitor the Participant for exacerbations.
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- Participants with serious intercurrent illness that requires active intravenous therapy, intense monitoring, or frequent dose adjustments for medication including but not limited to infectious disease, cancer, autoimmune disease, cardiovascular disease.
- Participants who have undergone major abdominal, thoracic, spine or central nervous system (CNS) surgery in the last 2 months, or plan to undergo surgery during study participation.
- Participants receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e. phenytoin, carbamazepine, Phenobarbital, primidone or oxcarbazepine) within 4 weeks of the start of the study treatment
- Participants currently taking digoxin
- History or evidence of increased cardiovascular risk including any of the following:
- Left ventricular ejection fraction (LVEF) < institutional lower limit of normal. Baseline echocardiogram is not required.
- Current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrollment
- Current ≥ Class II congestive heart failure as defined by New York Heart Association.
- Deemed unable to participate for medical reasons identified by Co-PI and study staff.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PATCH 2 & 3: (Prevention and Treatment of COVID-19 With Hydroxychloroquine) A Double-blind Placebo Controlled Randomized Trial of Hydroxychloroquine in the Prevention and Treatment of COVID-19
The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection. This hypothesis is based on a growing literature linking chloroquine to antiviral activity. It is estimated that enough information exists to launch a clinical trial of hydroxychloroquine for COVID-19.
Read the detailed description
Sub-Study 1: COVID-19 patients in self-quarantine. Group 1: Hydroxychloroquine 400 mg bid (two 200 mg tablets taken twice a day; totaling 800 mg per day) for two weeks; Group 2: Placebo 2 pills twice a day for two weeks
Sub-Study 2: Asymptomatic health care worker prophylaxis. Group 1: Hydroxychloroquine 600 mg once a day (three 200 mg tablets taken once a day) for up to 2 months; Group 2: Placebo 3 pills once a day for up to 2 months; cross-over from placebo to HCQ 600 mg once a day is allowed upon confirmatory diagnosis for COVID-19.
PRIMARY OBJECTIVES:
Sub-Study 1 (Patients tested for COVID-19 who meet symptomology and age requirements for eligibility): Rate of hospitalization
Sub-Study 2 (Health Care Workers): Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
SECONDARY OBJECTIVES Sub-Study 1: Rate of secondary infection of co-inhabitants, adverse events, and negative for COVID-19 (confirmed by accepted testing methods) at 14 days
Sub-Study 2: Number of shifts missed; rate of adverse events, and hospitalization at 2 months
- Conditions
- Coronavirus, Corona Virus Infection
- Being tested
- Group 1 HCQ, Group 2 Placebo
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 HCQDrug
Also called HCQ Group
Enrolled participants randomized in Group 1 receive the HCQ drug
Group 2 PlaceboDrug
Also called Placebo Group
Enrolled participants randomized in Group 2 will receive a placebo drug
| Study group | Role | What they receive |
|---|---|---|
| Sub Study 1 Patients | Experimental | Patients tested for COVID-19 who meet symptomology and age requirements for eligibility Receives: Drug: Group 1 HCQ; Drug: Group 2 Placebo |
| Sub Study 2 Health Care Workers | Experimental | Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months Receives: Drug: Group 1 HCQ; Drug: Group 2 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substudy 1 - Number of COVID-19+ PCR Patients in Self-quarantine Who Are Hospitalized
Number of COVID-19+ PCR patients in self-quarantine who are hospitalized up to 31 days after beginning HCQ or Placebo
Measured: Until completion of study, 29 to 31 days after beginning treatment.
Sub Study 2:Number of Health Care Workers Testing Positive at 2 Months
Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
Measured: Until completion of study, 2 months after start of treatment.
Secondary outcomes (6)
Sub Study 1 - Secondary Infection of Co-inhabitants of COVID-19 Positive PCR Patients in Self-quarantine
Co-inhabitants of COVID-19 positive PCR patients in self-quarantine that test positive up to 31 days after patient begins treatment with HCQ or Placebo
Measured: Until completion of study, 29 to 31 days after beginning treatment.
Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine
Rate of negative tests at end of treatment for COVID-19 positive PCR patients in self-quarantine
Measured: 15-17 days after completion of 14 day treatment
Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine
Rate of negative tests at end of treatment for COVID-19 positive PCR patients in self-quarantine
Measured: 1-3 days after completion of 14 day treatment
Sub Study 2:Health Care Workers:Number of Shifts Missed
Any work time missed because the participant experienced COVID-like symptoms during their active 2 month period
Measured: up to ~60 days after enrollment
Sub Study 2:Health Care Workers: Assessment of Any Medical Events That Occur During the ~60 Day Active Period
Assessment of any medical events that occur during the ~60 day active period that is felt to be related to receipt of HCQ
Measured: Until completion of study, 2 months (~60 days) after start of treatment.
Sub Study 2:Health Care Workers:Rate of Hospitalization
if the participant gets COVID and has severe symptoms and hospitalized, end point reached if before the end of the 2 month period
Measured: Until completion of study, 2 months after start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start7 Apr 2020
- Primary completion11 Jul 2020
- Study completion11 Jul 2020
Why it stopped: As enrollment began external studies called into question the safety and efficacy of hydroxychloroquine as a treatment which resulted in controversy. The timing of the controversy significantly impacted our ability to enroll and retain participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies 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
- Treatment and prevention study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- UnitedHealth Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProHealth Care Associates, University of Pennsylvania
- Responsible party
- Principal investigator, Dr. Deneen Vojta, UnitedHealth Group
- Investigators
- Deneen Vojta, MD, Principal investigator, UnitedHealth Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353037
- Sponsor's protocol ID
- 2020-0003
- Status last verified
- Oct 2021
- First submitted
- 9 Apr 2020
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be collected and managed by Optumcare and UnitedHealth Group Research \& Development. Redacted/aggregate data will be shared with the University Of Penn using approved data sharing protocols.
Publications
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Ong SWX, Tan YK, Chia PY, Lee TH, Ng OT, Wong MSY, Marimuthu K. Air, Surface Environmental, and Personal Protective Equipment Contamination by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) From a Symptomatic Patient. JAMA. 2020 Apr 28;323(16):1610-1612. doi: 10.1001/jama.2020.3227.
PubMed 32129805Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
PubMed 32125452Liu J, Liao X, Qian S, Yuan J, Wang F, Liu Y, Wang Z, Wang FS, Liu L, Zhang Z. Community Transmission of Severe Acute Respiratory Syndrome Coronavirus 2, Shenzhen, China, 2020. Emerg Infect Dis. 2020 Jun;26(6):1320-1323. doi: 10.3201/eid2606.200239. Epub 2020 Jun 17.
PubMed 32125269Li F. Receptor recognition mechanisms of coronaviruses: a decade of structural studies. J Virol. 2015 Feb;89(4):1954-64. doi: 10.1128/JVI.02615-14. Epub 2014 Nov 26.
PubMed 25428871Wang H, Yang P, Liu K, Guo F, Zhang Y, Zhang G, Jiang C. SARS coronavirus entry into host cells through a novel clathrin- and caveolae-independent endocytic pathway. Cell Res. 2008 Feb;18(2):290-301. doi: 10.1038/cr.2008.15.
PubMed 18227861Chu VC, McElroy LJ, Chu V, Bauman BE, Whittaker GR. The avian coronavirus infectious bronchitis virus undergoes direct low-pH-dependent fusion activation during entry into host cells. J Virol. 2006 Apr;80(7):3180-8. doi: 10.1128/JVI.80.7.3180-3188.2006.
PubMed 16537586Zheng Y, Shang J, Yang Y, Liu C, Wan Y, Geng Q, Wang M, Baric R, Li F. Lysosomal Proteases Are a Determinant of Coronavirus Tropism. J Virol. 2018 Nov 27;92(24):e01504-18. doi: 10.1128/JVI.01504-18. Print 2018 Dec 15.
PubMed 30258004Keyaerts E, Li S, Vijgen L, Rysman E, Verbeeck J, Van Ranst M, Maes P. Antiviral activity of chloroquine against human coronavirus OC43 infection in newborn mice. Antimicrob Agents Chemother. 2009 Aug;53(8):3416-21. doi: 10.1128/AAC.01509-08. Epub 2009 Jun 8.
PubMed 19506054Vincent MJ, Bergeron E, Benjannet S, Erickson BR, Rollin PE, Ksiazek TG, Seidah NG, Nichol ST. Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. Virol J. 2005 Aug 22;2:69. doi: 10.1186/1743-422X-2-69.
PubMed 16115318de Wilde AH, Jochmans D, Posthuma CC, Zevenhoven-Dobbe JC, van Nieuwkoop S, Bestebroer TM, van den Hoogen BG, Neyts J, Snijder EJ. Screening of an FDA-approved compound library identifies four small-molecule inhibitors of Middle East respiratory syndrome coronavirus replication in cell culture. Antimicrob Agents Chemother. 2014 Aug;58(8):4875-84. doi: 10.1128/AAC.03011-14. Epub 2014 May 19.
PubMed 24841269Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. No abstract available.
PubMed 32020029Amaravadi RK, Lippincott-Schwartz J, Yin XM, Weiss WA, Takebe N, Timmer W, DiPaola RS, Lotze MT, White E. Principles and current strategies for targeting autophagy for cancer treatment. Clin Cancer Res. 2011 Feb 15;17(4):654-66. doi: 10.1158/1078-0432.CCR-10-2634.
PubMed 21325294Rangwala R, Chang YC, Hu J, Algazy KM, Evans TL, Fecher LA, Schuchter LM, Torigian DA, Panosian JT, Troxel AB, Tan KS, Heitjan DF, DeMichele AM, Vaughn DJ, Redlinger M, Alavi A, Kaiser J, Pontiggia L, Davis LE, O'Dwyer PJ, Amaravadi RK. Combined MTOR and autophagy inhibition: phase I trial of hydroxychloroquine and temsirolimus in patients with advanced solid tumors and melanoma. Autophagy. 2014 Aug;10(8):1391-402. doi: 10.4161/auto.29119. Epub 2014 May 20.
PubMed 24991838
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATCH 2 & 3: (Prevention and Treatment of COVID-19 With Hydroxychloroquine) A Double-blind Placebo Controlled Randomized Trial of Hydroxychloroquine in the Prevention and Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04353037
- Acronym / sponsor ID
- 2020-0003
- Conditions
- Coronavirus, Corona Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As enrollment began external studies called into question the safety and efficacy of hydroxychloroquine as a treatment which resulted in controversy. The timing of the controversy significantly impacted our ability to enroll and retain participants.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- UnitedHealth GroupIndustry (pharma, biotech, devices)
- Collaborators
- ProHealth Care Associates, University of Pennsylvania
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 11 Jul 2020 (actual)
- Study completion
- 11 Jul 2020 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Posted 19 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection. This hypothesis is based on a growing literature linking chloroquine to antiviral activity. It is estimated that enough information exists to launch a clinical trial of hydroxychloroquine for COVID-19.
Detailed description
Sub-Study 1: COVID-19 patients in self-quarantine. Group 1: Hydroxychloroquine 400 mg bid (two 200 mg tablets taken twice a day; totaling 800 mg per day) for two weeks; Group 2: Placebo 2 pills twice a day for two weeks
Sub-Study 2: Asymptomatic health care worker prophylaxis. Group 1: Hydroxychloroquine 600 mg once a day (three 200 mg tablets taken once a day) for up to 2 months; Group 2: Placebo 3 pills once a day for up to 2 months; cross-over from placebo to HCQ 600 mg once a day is allowed upon confirmatory diagnosis for COVID-19.
PRIMARY OBJECTIVES:
Sub-Study 1 (Patients tested for COVID-19 who meet symptomology and age requirements for eligibility): Rate of hospitalization
Sub-Study 2 (Health Care Workers): Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
SECONDARY OBJECTIVES Sub-Study 1: Rate of secondary infection of co-inhabitants, adverse events, and negative for COVID-19 (confirmed by accepted testing methods) at 14 days
Sub-Study 2: Number of shifts missed; rate of adverse events, and hospitalization at 2 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Treatment and prevention study
| Arm | Type | Receives |
|---|---|---|
| Sub Study 1 Patients | Experimental | Drug: Group 1 HCQ, Drug: Group 2 PlaceboPatients tested for COVID-19 who meet symptomology and age requirements for eligibility |
| Sub Study 2 Health Care Workers | Experimental | Drug: Group 1 HCQ, Drug: Group 2 PlaceboRate of COVID-19 infection (confirmed by accepted testing methods) at 2 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Able to give informed consent
- Subjects meeting the following criteria by Sub-Study:
- Sub-Study 1: 50-75 years of age; self-reporting as having a fever within four days prior to time of enrollment; and not requiring hospitalization. Enrolled individuals will undergo testing for COVID-19 and sent home for self-quarantine.Participant must be willing and able to provide informed consent, agree to testing for COVID-19 at time of enrollment to confirm diagnosis and two weeks at the end of treatment.
- Sub-Study 2: Currently employed as a health care worker. Health care workers are defined as :
- Medical Doctor (MD)
Key exclusion criteria (16 listed)
- Allergy to hydroxychloroquine
- Pregnant or lactating or positive pregnancy test during pre-medication examination
- Receiving any trial treatment drug for 2019-ncov within 14 days prior to screening evaluation (off label, compassionate use or trial related).
- Known retinal disease including but not limited to macular degeneration, retinal vein occlusion, visual field defect, diabetic retinopathy
- History of interstitial lung disease or chronic pneumonitis unrelated COVID-19.
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 |
|---|---|---|
| Group 1 HCQAlso: HCQ GroupEnrolled participants randomized in Group 1 receive the HCQ drug | Drug | Sub Study 1 Patients, Sub Study 2 Health Care Workers |
| Group 2 PlaceboAlso: Placebo GroupEnrolled participants randomized in Group 2 will receive a placebo drug | Drug | Sub Study 1 Patients, Sub Study 2 Health Care Workers |
Primary outcome
Substudy 1 - Number of COVID-19+ PCR Patients in Self-quarantine Who Are Hospitalized
Time frame: Until completion of study, 29 to 31 days after beginning treatment.
Number of COVID-19+ PCR patients in self-quarantine who are hospitalized up to 31 days after beginning HCQ or Placebo
Sub Study 2:Number of Health Care Workers Testing Positive at 2 Months
Time frame: Until completion of study, 2 months after start of treatment.
Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
6 secondary outcomes
Sub Study 1 - Secondary Infection of Co-inhabitants of COVID-19 Positive PCR Patients in Self-quarantine
Time frame: Until completion of study, 29 to 31 days after beginning treatment.
Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine
Time frame: 15-17 days after completion of 14 day treatment
Sub Study 1 - Rate of Negative Tests at End of Treatment for COVID-19 Positive PCR Patients in Self-quarantine
Time frame: 1-3 days after completion of 14 day treatment
Sub Study 2:Health Care Workers:Number of Shifts Missed
Time frame: up to ~60 days after enrollment
Sub Study 2:Health Care Workers: Assessment of Any Medical Events That Occur During the ~60 Day Active Period
Time frame: Until completion of study, 2 months (~60 days) after start of treatment.
Sub Study 2:Health Care Workers:Rate of Hospitalization
Time frame: Until completion of study, 2 months after start of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Background: PubMed 32129805Ong SWX, Tan YK, Chia PY, Lee TH, Ng OT, Wong MSY, Marimuthu K. Air, Surface Environmental, and Personal Protective Equipment Contamination by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) From a Symptomatic Patient. JAMA. 2020 Apr 28;323(16):1610-1612. doi: 10.1001/jama.2020.3227.
- Background: PubMed 32125452Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
- Background: PubMed 32125269Liu J, Liao X, Qian S, Yuan J, Wang F, Liu Y, Wang Z, Wang FS, Liu L, Zhang Z. Community Transmission of Severe Acute Respiratory Syndrome Coronavirus 2, Shenzhen, China, 2020. Emerg Infect Dis. 2020 Jun;26(6):1320-1323. doi: 10.3201/eid2606.200239. Epub 2020 Jun 17.
- Background: PubMed 25428871Li F. Receptor recognition mechanisms of coronaviruses: a decade of structural studies. J Virol. 2015 Feb;89(4):1954-64. doi: 10.1128/JVI.02615-14. Epub 2014 Nov 26.
- Background: PubMed 18227861Wang H, Yang P, Liu K, Guo F, Zhang Y, Zhang G, Jiang C. SARS coronavirus entry into host cells through a novel clathrin- and caveolae-independent endocytic pathway. Cell Res. 2008 Feb;18(2):290-301. doi: 10.1038/cr.2008.15.
- Background: PubMed 16537586Chu VC, McElroy LJ, Chu V, Bauman BE, Whittaker GR. The avian coronavirus infectious bronchitis virus undergoes direct low-pH-dependent fusion activation during entry into host cells. J Virol. 2006 Apr;80(7):3180-8. doi: 10.1128/JVI.80.7.3180-3188.2006.
- Background: PubMed 30258004Zheng Y, Shang J, Yang Y, Liu C, Wan Y, Geng Q, Wang M, Baric R, Li F. Lysosomal Proteases Are a Determinant of Coronavirus Tropism. J Virol. 2018 Nov 27;92(24):e01504-18. doi: 10.1128/JVI.01504-18. Print 2018 Dec 15.
- Background: PubMed 19506054Keyaerts E, Li S, Vijgen L, Rysman E, Verbeeck J, Van Ranst M, Maes P. Antiviral activity of chloroquine against human coronavirus OC43 infection in newborn mice. Antimicrob Agents Chemother. 2009 Aug;53(8):3416-21. doi: 10.1128/AAC.01509-08. Epub 2009 Jun 8.
- Background: PubMed 16115318Vincent MJ, Bergeron E, Benjannet S, Erickson BR, Rollin PE, Ksiazek TG, Seidah NG, Nichol ST. Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. Virol J. 2005 Aug 22;2:69. doi: 10.1186/1743-422X-2-69.
- Background: PubMed 24841269de Wilde AH, Jochmans D, Posthuma CC, Zevenhoven-Dobbe JC, van Nieuwkoop S, Bestebroer TM, van den Hoogen BG, Neyts J, Snijder EJ. Screening of an FDA-approved compound library identifies four small-molecule inhibitors of Middle East respiratory syndrome coronavirus replication in cell culture. Antimicrob Agents Chemother. 2014 Aug;58(8):4875-84. doi: 10.1128/AAC.03011-14. Epub 2014 May 19.
- Individual participant dataSharing planned: Yes. Data will be collected and managed by Optumcare and UnitedHealth Group Research \& Development. Redacted/aggregate data will be shared with the University Of Penn using approved data sharing protocols.
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Post-Acute COVID-19 Syndrome
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A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
Deneen Vojta, MD principal investigator
UnitedHealth Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group 1 HCQ in people with Coronavirus and Corona Virus Infection, run by UnitedHealth Group at 1 site in United States.
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 26 inclusion and 16 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: stopped early, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Substudy 1 - Number of COVID-19+ PCR Patients in Self-quarantine Who Are Hospitalized (time frame: Until completion of study, 29 to 31 days after beginning treatment.). The study lists 2 primary outcomes in all. 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 NCT04353037, which also lists 17 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 19 Oct 2021.