Covid 19Phase 2/3THICKNCT04353271
Trial of Hydroxychloroquine In Covid-19 Kinetics
A Phase 2/3 study testing Hydroxychloroquine in people with Covid 19 and Corona Virus Infection, run by University of South Alabama at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Covid 19, Corona Virus Infection
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2020to 8 Jul 2020
- Phase
- Phase 2/3
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics
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.
Read the detailed description
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
- Covid 19, Corona Virus Infection
- Being tested
- Hydroxychloroquine, Placebo
- Keywords
- covid 19, plaquenil, hydroxychloroquine
- 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.
Also called plaquenil
Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days.
PlaceboOther
Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Subjects in this arm will receive the study drug Receives: Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Subjects in this arm will take placebo for 6 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Are Virus Free
Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs
Measured: 7 days after initiation of trial
Disease Severity
Participants will self-report disease severity status as one of the following 5 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization (score of 3), or Covid 19 with care requiring hospitalization (score of 4), or Covid 19 with death (Score of 5) .
Measured: 6 days
Secondary outcomes (5)
Number of Participants Who Are Hospitalized for Covid 19 Infection
Number of subjects in each arm who are hospitalized for Covid 19 infection
Measured: 14 days
Number of Participants Who Die Secondary to Covid 19 Infection
Number of subjects in each arm who die secondary to Covid-19 infection
Measured: 70 Days (10 weeks)
Number of Participants Who Have Confirmed Covid 19 Infection
Number of subjects in each arm who have confirmed Covid-19 infection
Measured: 14 days
Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason
Number of subjects in each arm who discontinue or withdraw medication use for any reason
Measured: 14 days
Immunity to Covid-19
Blood tests to determine level of immunity in each subject
Measured: 70 days (10 weeks)
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 start17 Apr 2020
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Why it stopped: FDA recommendations to not use outside of the hospital setting or in a clinical trial due to the risk of cardiac arrhythmias
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 (29)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo verses medication clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Richards, University of South Alabama
- Investigators
- William O Richards, MD, Principal investigator, University of South Alabama College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353271
- Sponsor's protocol ID
- [1582736-1]
- Acronym
- THICK
- Status last verified
- Dec 2021
- First submitted
- 25 Mar 2020
- Last updated
- 3 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Percival I. Nuclear winter. Practitioner. 1988 Feb 8;232(1442):140-1. No abstract available.
PubMed 3217330Gao 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.
PubMed 32074550Liu 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 32194981Gautret 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 32205204Yao 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 32150618Sahraei 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.
PubMed 32194152Colson 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.
PubMed 32145363Stokkermans TJ, Falkowitz DM, Trichonas G. Chloroquine and Hydroxychloroquine Toxicity. 2024 Jan 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537086/
PubMed 30725771Baden 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.
PubMed 32187463Zhou 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.
PubMed 32196083Chan 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.
PubMed 32164424Dong 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.
PubMed 32147628Beigelman 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.
PubMed 26215052Jiang 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.
PubMed 32179860Cascella 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; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
PubMed 32150360
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics
- ClinicalTrials.gov ID
- NCT04353271
- Acronym / sponsor ID
- THICK / [1582736-1]
- Conditions
- Covid 19, Corona Virus Infection
- Keywords
- covid 19, plaquenil, hydroxychloroquine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA recommendations to not use outside of the hospital setting or in a clinical trial due to the risk of cardiac arrhythmias
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Posted 3 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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
- Randomized placebo verses medication clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: HydroxychloroquineSubjects in this arm will receive the study drug |
| Placebo | Placebo comparator | Other: PlaceboSubjects in this arm will take placebo for 6 days |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| HydroxychloroquineAlso: plaquenilHydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days. | Drug | Hydroxychloroquine |
| PlaceboPlacebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days. | Other | Placebo |
Primary outcome
Number of Participants Who Are Virus Free
Time frame: 7 days after initiation of trial
Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs
Disease Severity
Time frame: 6 days
Participants will self-report disease severity status as one of the following 5 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization (score of 3), or Covid 19 with care requiring hospitalization (score of 4), or Covid 19 with death (Score of 5) .
5 secondary outcomes
Number of Participants Who Are Hospitalized for Covid 19 Infection
Time frame: 14 days
Number of Participants Who Die Secondary to Covid 19 Infection
Time frame: 70 Days (10 weeks)
Number of Participants Who Have Confirmed Covid 19 Infection
Time frame: 14 days
Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason
Time frame: 14 days
Immunity to Covid-19
Time frame: 70 days (10 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3217330Percival I. Nuclear winter. Practitioner. 1988 Feb 8;232(1442):140-1. No abstract available.
- Background: PubMed 32074550Gao 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.
- 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 32205204Gautret 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.
- 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 32194152Sahraei 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.
- Background: PubMed 32145363Colson 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.
- Background: PubMed 30725771Stokkermans TJ, Falkowitz DM, Trichonas G. Chloroquine and Hydroxychloroquine Toxicity. 2024 Jan 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537086/
- Background: PubMed 32187463Baden 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.
- Background: PubMed 32196083Zhou 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.
- Background: PubMed 32164424Chan 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.
- Background: PubMed 32147628Dong 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.
- Individual participant dataSharing planned: No
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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.
William O Richards, MD principal investigator
University of South Alabama College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydroxychloroquine in people with Covid 19 and Corona Virus Infection, run by University of South Alabama 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 17 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 3 Jan 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. 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 combined 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.
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 3 Jan 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?
Number of Participants Who Are Virus Free (time frame: 7 days after initiation of trial). 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 NCT04353271, which also lists 29 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 3 Jan 2022.