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COVID-19Phase 3WHIP COVID-19NCT04341441

Will Hydroxychloroquine Impede or Prevent COVID-19

A Phase 3 study testing Hydroxychloroquine - Daily Dosing, Hydroxychloroquine - Weekly Dosing and Monitoring Visit - Baseline in people with COVID-19 and Coronavirus, run by Henry Ford Health System at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, Coronavirus, Coronavirus Infections
What is being tested?
Hydroxychloroquine - Daily Dosing, Hydroxychloroquine - Weekly Dosing and Monitoring Visit - Baseline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
624 participants
Where
1 siteUnited States
Study dates
7 Apr 2020to 15 Dec 2020
Phase
Phase 3
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

  • Participant is willing and able to provide informed consent.
  • Participant is 18-75 years of age.
  • Participant does not have symptoms of respiratory infection, including cough, fevers (temperature >38.0C), difficulty breathing, shortness of breath, chest pains, malaise, myalgia, headaches, nausea or vomiting, or other symptoms associated with COVID-19.
  • Participant is willing to provide blood samples for the study.
  • Subject agrees to all aspects of the study.
  • The participant has no known allergies or contraindications (as stated in the consent form) to the use of hydroxychloroquine (HCQ) as noted in the exclusion criteria and Pharmacy sections.

Who cannot join

  • Does not meet inclusion criteria.
  • Participant unable or unwilling to provide informed consent.
  • Participant has any of the symptoms above or screens positive for possible COVID-19 disease.
  • Participant is currently enrolled in a study to evaluate an investigational drug.
  • Vulnerable populations deemed inappropriate for study by the site Principal Investigator.
  • The participant has a known allergy/hypersensitivity or has a medication or co-morbidity (including history of gastric bypass, epilepsy, cardiovascular disease or renal failure) that prevents the use of HCQ (see pharmacy section).
Show all 15Show fewer
  • The participant is a woman of childbearing age whose pregnancy status is unknown and is not willing to use 2 methods of contraception.
  • The participant is pregnant or nursing.
  • The participant was diagnosed with retinopathy prior to study entry.
  • The participant has a diagnosis of porphyria prior to study entry.
  • The participant has renal failure with a creatinine clearance of <10 ml/min, pre-dialysis or requiring dialysis.
  • The Participant has a family history of Sudden Cardiac Death.
  • The participant is currently on diuretic therapy.
  • The participant has a history of known Prolonged QT Syndrome.
  • The participant is already taking any of the following medications: Abiraterone acetate, Agalsidase, Amodiaquine, Azithromycin, Conivaptan, Dabrafenib, Dacomitinib, Dapsone (Systemic), Digoxin, Enzalutamide, Fusidic Acid (Systemic), Idelalisib, Lanthanum, Lumefantrine, Mefloquine, Mifepristone, Mitotane, Pimozide, QT-prolonging Agents, Stiripentol).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Henry Ford Hospital

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: Will Hydroxychloroquine Impede or Prevent COVID-19: WHIP COVID-19 Study

This is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection

The primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Southeast Michigan.

Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.

Read the detailed description

The study will randomize a total of 3,000 HCW, NHW, FR and DDOT bus drivers within Henry Ford Hospital System, the Detroit COVID Consortium in Southeast, Michigan. The participants will be randomized in a 1:1:1 blinded comparison of daily HCQ, weekly HCQ, or placebo. A fourth non-randomized comparator group of HCW, NHW, DDOT bus drivers, and FR who are currently on standard HCQ therapy will be recruited to assess the impact of weightbased daily dosing of HCQ as compared to the randomized arms.

Eligible participants who are asymptomatic for pre-specified signs and symptoms suggestive of COVID-19 infection will have a whole blood specimen obtained at study entry.

Participants will be provided with weekly dosing of hydroxychloroquine (HCQ) 400mg po q weekly, daily dosing of HCQ 200mg po q daily following a loading dose of 400mg day 1, or placebo. Participants will receive monitoring at each study week visit to assess for the development of COVID-19 related symptoms, COVID-19 clinical disease, and medication side effects. At week 8 or if diagnosed positive, participants will provide additional samples of whole blood and complete the final study questionnaire.

Data including demographic, clinical results, work duties, location of main work area and possible exposures in the community will be collected through questionnaires and EMR review. Disease-specific, immunologic, and other serologic marker data will be obtained from stored samples.

Being tested
Hydroxychloroquine - Daily Dosing, Hydroxychloroquine - Weekly Dosing, Placebo oral tablet, Monitoring Visit - Baseline, Monitoring Visit - Week 4
Keywords
COVID-19, Coronavirus, Healthcare Workers, SARS-CoV 2, First Responders, Emergency Medical Technicians, Paramedics, Firefighters, Police Officers, Detroit, Michigan, Henry Ford Hospital
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydroxychloroquine - Daily DosingDrug

    Also called Study Drug - Daily, Daily Oral Dosing

    The daily hydroxychloroquine treatment arm will receive a 200 mg oral dose daily following day 1 dose of 400 mg orally once. This dose represents approximately half the standard weight-based dosing recommended for management of autoimmune diseases and therefore less likely to produce side effects than standard of care.

    All treatment groups will receive placebo pills to have the patients take 2 pills a day.

  • Hydroxychloroquine - Weekly DosingDrug

    Also called Weekly Oral Dosing

    The once weekly randomized treatment arm will receive the proposed dose of hydroxychloroquine for prophylaxis of malaria is 6.5 mg/kg per dose (maximum of 400 mg per dose) administered orally weekly on the same day of each week. This is based on the recommended dose for prophylaxis of malaria

    All treatment groups will receive placebo pills to have the patients take 2 pills a day.

  • Placebo oral tabletOther

    Also called Placebo

    Participants randomized to this arm will be provided with daily dosing of oral placebo to have the patients take 2 pills a day..

    Participants will receive a monitoring phone call at 4 weeks post study entry to monitor for COVID-19 symptoms and medication side effects. At week 8, participants will provide additional samples of whole blood.

    Additional studies will include serology, inflammatory and other disease associated markers. Clinical data and location of main work area will be collected.

  • Monitoring Visit - BaselineDiagnostic test

    Also called Baseline Monitoring Visit

    Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

  • Monitoring Visit - Week 4Diagnostic test

    Also called Week 4 - Monitoring Visit

    Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

  • Monitoring Visit - Week 8Diagnostic test

    Also called Week 8 - Monitoring Visit

    Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

  • Weekly AssessmentOther

    Also called Monitoring Call

    Participants will be asked to contact the study team if COVID-19 infection is established at any time during the study. For study weeks 1,2,3,5,6 \&7, Participants will receive a monitoring questionnaire to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects. These monitoring visits will be done by telephone and/or electronic encounters (virtual visits, email), whichever method the patient prefers to encourage adherence to the monitoring.

Study groups in NCT04341441
Study groupRoleWhat they receive
Study Drug - Daily DoseActive comparatorThe daily hydroxychloroquine treatment arm will receive a 200 mg oral dose daily following day 1 dose of 400 mg orally once. This dose represents approximately half the standard weight-based dosing recommended for management of autoimmune diseases and therefore less likely to produce side effects than standard of care.
Receives: Drug: Hydroxychloroquine - Daily Dosing; Diagnostic Test: Monitoring Visit - Baseline; Diagnostic Test: Monitoring Visit - Week 4; Diagnostic Test: Monitoring Visit - Week 8; Other: Weekly Assessment
Study Drug - Weekly DoseActive comparatorThe once weekly randomized treatment arm will receive the proposed dose of hydroxychloroquine for prophylaxis of malaria is 6.5 mg/kg per dose (maximum of 400mg per dose) administered orally weekly on the same day of each week. This is based on the recommended dose for prophylaxis of malaria.
Receives: Drug: Hydroxychloroquine - Weekly Dosing; Diagnostic Test: Monitoring Visit - Baseline; Diagnostic Test: Monitoring Visit - Week 4; Diagnostic Test: Monitoring Visit - Week 8; Other: Weekly Assessment
PlaceboActive comparatorAll treatment groups will receive placebo pills to have the patients take 2 pills a day. The randomized placebo arm will receive placebo pills made to resemble the daily dosing of HCQ. Similarly, the once a week treatment arm will receive placebo pills for the days not on HCQ medication.
Receives: Other: Placebo oral tablet; Diagnostic Test: Monitoring Visit - Baseline; Diagnostic Test: Monitoring Visit - Week 4; Diagnostic Test: Monitoring Visit - Week 8; Other: Weekly Assessment
Non-Randomized Active ComparatorActive comparatorA non-randomized comparator group will be enrolled in the study comprising of healthcare workers and first responders who are chronically on oral hydroxychloroquine as part of their standard of care for their autoimmune disease(s). This will be an open enrollment group and will provide information of chronic weight-based daily therapy of HCQ effectiveness as a prophylactic/preventive strategy.
Receives: Diagnostic Test: Monitoring Visit - Baseline; Diagnostic Test: Monitoring Visit - Week 4; Diagnostic Test: Monitoring Visit - Week 8; Other: Weekly Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To Determine if the Use of Hydroxychloroquine as Preventive Therapy Decreases the Rate of Acquisition of SARS-CoV 2 Infections With Clinical COVID-19 Disease in Study Participants for Each Randomized Treatment Arm as Compared to Placebo.

    The rate of acquisition of SARS-CoV 2 infections and clinical COVID-19 disease (number of events) in study participants for each randomized hydroxychloroquine treatment arm was compared to the placebo treatment arm. This included both symptomatic and asymptomatic patients.

    Measured: 8 Weeks

Secondary outcomes (10)

  1. Determine the Effect of Hydroxychloroquine Dose in the Prevention of COVID-19 Viremia and Disease.

    Compare the rates of SARS-CoV 2 symptomatic infections (number of events with both symptoms and positive test for COVID-19) between the randomized hydroxychloroquine treatment arms and the placebo control arm to determine the effect of HCQ dose in the prevention of COVID-19 viremia and disease. This analysis only includes only the randomized arms in the study (Study Drug - Daily Dose, Study Drug - Weekly Dose, and Placebo).

    Measured: 8 Weeks

  2. Assess the Impact of Chronic Weight-based Dosing of HCQ for COVID-19 Prevention.

    Compare the rates of SARS-CoV 2 infections (number of events of symptomatic patients with a positive COVID-19 test) in the non-randomized comparator arm to the randomized hydroxychloroquine and placebo arms to assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention via weekly questionnaire and/or blood samples. This analysis includes all randomized and non-randomized groups in the study.

    Measured: 8 Weeks

  3. Comparison of the Rate of SARS-CoV 2 Infections as Measured by IgM/IgG Seroconversion in Study Participants Receiving Randomized HCQ Versus Placebo.

    Measurement of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo via blood samples in the randomized arms of the study (Study Drug - Daily Dose, Study Drug - Weekly Dose, and Placebo).

    Measured: 8 Weeks

  4. Compare the Seroprevalence of SARS-CoV 2 IgM and/or IgG Positive Samples at Study Entry and Study Conclusion in All Participants Receiving HCQ Compared to Those Receiving Placebo.

    Measurement of the seroprevalence of SARS-CoV 2 IgM and/or IgG positive samples in all arms of the study, randomized and non-randomized (Study Drug - Daily Dose, Study Drug - Weekly Dose, Placebo, and Non-Randomized Active Comparator).

    Measured: 8 Weeks

  5. Comparison of the Emergence of Clinical Symptoms or COVID-19 Diagnosis in Participants Presenting Asymptomatically at Study Entry But Identified as Seropositive by Serology at Entry Between the Randomized Treatment Arms and Comparator Arm.

    Measurement of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm and via weekly questionnaire and/or blood samples.

    Measured: 8 Weeks

  6. To Examine the Level of Care Needed by Participants in Each Arm Developing COVID19 as Measured as Requiring Emergency Room Visit, Hospitalization or Able to Stay Home Without Hospital Care.

    Review of the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care via weekly questionnaire.

    Measured: 8 Weeks

  7. Determine the Safety and Tolerability of HCQ Dosing for Preventive Strategy Against COVID-19 as Measured by Adverse Events and Serious Adverse Events.

    Measurement of the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events reported via weekly questionnaire.

    Measured: 8 Weeks

  8. To Examine Other Clinical Factors Contributing to the Risk of SARS-CoV 2 Infection in Healthcare Workers and First Responders.

    Examination of other clinical factors contributing to the risk of SARS-CoV 2 infection including demographics, work type and location, positive COVID-19 partners, possible exposures and clinical symptoms via study visits and weekly questionnaire.

    Measured: 8 Weeks

  9. Examine the Correlation Between HCQ Drug Levels and Development of COVID-19 Symptoms or Positive COVID-19 Test Results.

    Examination of the correlation between HCQ drug levels and development of COVID-19 clinical symptoms and/or positive COVID-19 test results via weekly subject questionnaire and/or blood samples.

    Measured: 8 Weeks

  10. Identify Immunologic, Serological and Inflammatory Markers Associated With Acquisition and Response to COVID-19 in Both HCQ and Placebo Participants Developing Laboratory or Clinical Confirmed Disease.

    Identification of immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease via study visits, weekly questionnaire, and blood samples.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2020
  2. Study start7 Apr 2020
  3. Primary completion15 Dec 2020
  4. Study completion15 Dec 2020

Why it stopped: Interim analysis did not reveal any safety concerns by the DSMB, but unblinded data did not provide support to continue. Event rate did not meet projected magnitude; given low recruitment potential, it is unlikely that a positive result will occur.

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW) and first responders (FR) in southeast (SE) Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection. The study will randomize a total of 3,000 Healthcare Workers and First Responders, age ≥18 years or older, through the Henry Ford Health System, Detroit COVID Consortium. The participants who meeting study entry criteria and are not on HCQ prior to study enrollment will be randomized in a 1:1:1 blinded comparison of daily or weekly oral hydroxychloroquine versus oral placebo for 8 weeks. A fourth non-randomized comparator group will be enrolled in the study comprising of HCW who are chronically on HCQ as part of their standard of care for their autoimmune disease(s). This will be an open enrollment group and will provide information of chronic weight-based daily therapy of HCQ effectiveness as a prophylactic/preventive strategy.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04341441
Sponsor's protocol ID
1410401
Acronym
WHIP COVID-19
Status last verified
Jun 2022
First submitted
7 Apr 2020
Last updated
21 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.

    PubMed 32083643

  • Chang D, Xu H, Rebaza A, Sharma L, Dela Cruz CS. Protecting health-care workers from subclinical coronavirus infection. Lancet Respir Med. 2020 Mar;8(3):e13. doi: 10.1016/S2213-2600(20)30066-7. Epub 2020 Feb 13. No abstract available.

    PubMed 32061333

  • 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.

    PubMed 32194981

  • Vincent 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 16115318

  • Ben-Zvi I, Kivity S, Langevitz P, Shoenfeld Y. Hydroxychloroquine: from malaria to autoimmunity. Clin Rev Allergy Immunol. 2012 Apr;42(2):145-53. doi: 10.1007/s12016-010-8243-x.

    PubMed 21221847

  • Mohammad S, Clowse MEB, Eudy AM, Criscione-Schreiber LG. Examination of Hydroxychloroquine Use and Hemolytic Anemia in G6PDH-Deficient Patients. Arthritis Care Res (Hoboken). 2018 Mar;70(3):481-485. doi: 10.1002/acr.23296. Epub 2018 Feb 9.

    PubMed 28556555

  • 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.

    PubMed 32205204

  • 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.

    PubMed 32150618

  • Lim HS, Im JS, Cho JY, Bae KS, Klein TA, Yeom JS, Kim TS, Choi JS, Jang IJ, Park JW. Pharmacokinetics of hydroxychloroquine and its clinical implications in chemoprophylaxis against malaria caused by Plasmodium vivax. Antimicrob Agents Chemother. 2009 Apr;53(4):1468-75. doi: 10.1128/AAC.00339-08. Epub 2009 Feb 2.

    PubMed 19188392

  • Howard DR, Brown JM, Todd S, Gregory WM. Recommendations on multiple testing adjustment in multi-arm trials with a shared control group. Stat Methods Med Res. 2018 May;27(5):1513-1530. doi: 10.1177/0962280216664759. Epub 2016 Sep 19.

    PubMed 27647808

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydroxychloroquine - Daily Dosing, Hydroxychloroquine - Weekly Dosing and Monitoring Visit - Baseline in people with COVID-19 and Coronavirus, run by Henry Ford Health System 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 6 inclusion and 15 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 21 Jun 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Jun 2022). 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?

To Determine if the Use of Hydroxychloroquine as Preventive Therapy Decreases the Rate of Acquisition of SARS-CoV 2 Infections With Clinical COVID-19 Disease in Study Participants for Each Randomized Treatment Arm as Compared to Placebo. (time frame: 8 Weeks). 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 NCT04341441, which also lists 10 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 21 Jun 2022.

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