Covid19NCT04349592
Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
A study testing Hydroxychloroquine and Azithromycin in people with Covid19, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Hydroxychloroquine and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 1 siteQatar
- Study dates
- 14 Apr 2020to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is in HMC facility for low-acuity, Covid-positive patients being quarantined.
- Positive Covid test on qualitative assay used during routine care (i.e. not as part of Q-PROTECT)
- Age at least 18
Who cannot join
- Treating physician judges patient not appropriate for study participation for any reason
- Age <18
- Breastfeeding or pregnancy (patient-reported pregnancy status is sufficient)
- Hypersensitivity to chloroquine or HC or AZ
- History of or known QT prolongation
- EKG required before study entry and on each visit during the subject's first seven days on pro-tocol, during the time period HC is being taken
Show all 16Show fewer
- Baseline QTc >480 if QRS width normal; QTc >510 if QRS >120
- Known G6PD deficiency, porphyria, or retinopathy (eye exam prior to study entry)
- Known hepatic or renal disease (or abnormality on liver or renal function testing at study day 1)
- Low magnesium or low potassium (by testing on day 1)
- Current (pre-study) therapy with antimalarial or dapsone
- Current (pre-study) therapy with antiviral agents (e.g. oseltamivir)
- Tisdale36 score exceeding 6 as tallied below (based on ACC recommendations)*
- 1 point each: age>67, female sex, or being on loop diuretic
- 2 points each: serum potassium <3.6, QTc>449, acute myocardial infarction
- 3 points each: sepsis, heart failure, QT-prolonging drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
Read the detailed description
Reducing viral load is potentially key to reducing viral transmission between humans. Observational data suggests HC and AZ may reduce the viral load. In this study we will randomise ambulatory patients with Covid 19 (confirmed by PCR in combination with clinical symptoms) to receive HC/AZ or HC/placebo or placebo for 7 days. On days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ECG recorded and physical examination performed. On days 15-20, participants will be reviewed by telephone using a semi structured questionnaire. On day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for PCR analysis. Participants will be followed for 6 months via their medical records.
- Conditions
- Covid19
- Being tested
- Hydroxychloroquine, Azithromycin, Placebo Tablet, Placebo capsules
- Keywords
- Covid19, Qatar, Coronavirus, Hydroxychloroquine, Respiratory disease, Pandemic, Azithromycin, Viral Load, Emergency Department, SARS-CoV-2
- Medical subject headings
- COVID-19, Coronavirus Infections, Respiration Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil,
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
AzithromycinDrug
Also called Zithromax, Azithrocin
Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
Placebo TabletOther
Oral, one tablet three times a day for 7 days
Placebo capsulesOther
Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy group | Experimental | hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5 Receives: Drug: Hydroxychloroquine; Drug: Azithromycin |
| Monotherapy therapy group | Active comparator | hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5 Receives: Drug: Hydroxychloroquine; Other: Placebo capsules |
| Control group | Placebo comparator | Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5 Receives: Other: Placebo Tablet; Other: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of virologically cured (PCR-negative status) as assessed on day six
Days
Measured: Day 6
Secondary outcomes (5)
virologic cure on other study days
Days
Measured: Day14 and Day 21
virologic semiquantitative analysis of changing viral load
Days
Measured: Day 1 to Day 21
proportion of initially symtomatic subjects with disappearance of clinical symptoms
Days
Measured: Day14 and Day 21
proportion of initially asymtomatic subjects with appearance of new clinical symptoms
Days
Measured: Day14 and Day 21
proportions of subjects with potentially medication- related adverse events
grades
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start14 Apr 2020
- Primary completion14 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Tim Richard Edmund Harris, Hamad Medical Corporation
- Investigators
- Tim R Harris, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349592
- Sponsor's protocol ID
- MRC-05-001
- Status last verified
- Feb 2021
- First submitted
- 12 Apr 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PubMed 31978945Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Xu Z, Li S, Tian S, Li H, Kong LQ. Full spectrum of COVID-19 severity still being depicted. Lancet. 2020 Mar 21;395(10228):947-948. doi: 10.1016/S0140-6736(20)30308-1. Epub 2020 Feb 14. No abstract available.
PubMed 32066525Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
PubMed 32085846Xu XW, Wu XX, Jiang XG, Xu KJ, Ying LJ, Ma CL, Li SB, Wang HY, Zhang S, Gao HN, Sheng JF, Cai HL, Qiu YQ, Li LJ. Clinical findings in a group of patients infected with the 2019 novel coronavirus (SARS-Cov-2) outside of Wuhan, China: retrospective case series. BMJ. 2020 Feb 19;368:m606. doi: 10.1136/bmj.m606.
PubMed 32075786Van Cuong L, Giang HTN, Linh LK, Shah J, Van Sy L, Hung TH, Reda A, Truong LN, Tien DX, Huy NT. The first Vietnamese case of COVID-19 acquired from China. Lancet Infect Dis. 2020 Apr;20(4):408-409. doi: 10.1016/S1473-3099(20)30111-0. Epub 2020 Feb 19. No abstract available.
PubMed 32085849Wang CJ, Ng CY, Brook RH. Response to COVID-19 in Taiwan: Big Data Analytics, New Technology, and Proactive Testing. JAMA. 2020 Apr 14;323(14):1341-1342. doi: 10.1001/jama.2020.3151. No abstract available.
PubMed 32125371Adalja AA, Toner E, Inglesby TV. Priorities for the US Health Community Responding to COVID-19. JAMA. 2020 Apr 14;323(14):1343-1344. doi: 10.1001/jama.2020.3413. No abstract available.
PubMed 32125355Anderson M, Mckee M, Mossialos E. Covid-19 exposes weaknesses in European response to outbreaks. BMJ. 2020 Mar 18;368:m1075. doi: 10.1136/bmj.m1075. No abstract available.
PubMed 32188590Chatterjee P. Indian pharma threatened by COVID-19 shutdowns in China. Lancet. 2020 Feb 29;395(10225):675. doi: 10.1016/S0140-6736(20)30459-1. No abstract available.
PubMed 32113494Mahase E. Covid-19: WHO declares pandemic because of "alarming levels" of spread, severity, and inaction. BMJ. 2020 Mar 12;368:m1036. doi: 10.1136/bmj.m1036. No abstract available.
PubMed 32165426Wong JEL, Leo YS, Tan CC. COVID-19 in Singapore-Current Experience: Critical Global Issues That Require Attention and Action. JAMA. 2020 Apr 7;323(13):1243-1244. doi: 10.1001/jama.2020.2467. No abstract available.
PubMed 32077901Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.
PubMed 32004427Mahase E. Covid-19: UK starts social distancing after new model points to 260 000 potential deaths. BMJ. 2020 Mar 17;368:m1089. doi: 10.1136/bmj.m1089. No abstract available.
PubMed 32184205Duan L, Zhu G. Psychological interventions for people affected by the COVID-19 epidemic. Lancet Psychiatry. 2020 Apr;7(4):300-302. doi: 10.1016/S2215-0366(20)30073-0. Epub 2020 Feb 19. No abstract available.
PubMed 32085840
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
- ClinicalTrials.gov ID
- NCT04349592
- Acronym / sponsor ID
- MRC-05-001
- Conditions
- Covid19
- Keywords
- Covid19, Qatar, Coronavirus, Hydroxychloroquine, Respiratory disease, Pandemic, Azithromycin, Viral Load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
Detailed description
Reducing viral load is potentially key to reducing viral transmission between humans. Observational data suggests HC and AZ may reduce the viral load. In this study we will randomise ambulatory patients with Covid 19 (confirmed by PCR in combination with clinical symptoms) to receive HC/AZ or HC/placebo or placebo for 7 days. On days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ECG recorded and physical examination performed. On days 15-20, participants will be reviewed by telephone using a semi structured questionnaire. On day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for PCR analysis. Participants will be followed for 6 months via their medical records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination therapy group | Experimental | Drug: Hydroxychloroquine, Drug: Azithromycinhydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5 |
| Monotherapy therapy group | Active comparator | Drug: Hydroxychloroquine, Other: Placebo capsuleshydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5 |
| Control group | Placebo comparator | Other: Placebo Tablet, Other: Placebo capsulesPlacebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is in HMC facility for low-acuity, Covid-positive patients being quarantined.
- Positive Covid test on qualitative assay used during routine care (i.e. not as part of Q-PROTECT)
- Age at least 18
Key exclusion criteria (16 listed)
- Treating physician judges patient not appropriate for study participation for any reason
- Age <18
- Breastfeeding or pregnancy (patient-reported pregnancy status is sufficient)
- Hypersensitivity to chloroquine or HC or AZ
- History of or known QT prolongation
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: Plaquenil,Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days | Drug | Combination therapy group, Monotherapy therapy group |
| AzithromycinAlso: Zithromax, AzithrocinAzithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5. | Drug | Combination therapy group |
| Placebo TabletOral, one tablet three times a day for 7 days | Other | Control group |
| Placebo capsulesOral 2 capsules on day one, followed by 1 capsule once a day for days 2-5. | Other | Control group, Monotherapy therapy group |
Primary outcome
Proportion of virologically cured (PCR-negative status) as assessed on day six
Time frame: Day 6
Days
5 secondary outcomes
virologic cure on other study days
Time frame: Day14 and Day 21
virologic semiquantitative analysis of changing viral load
Time frame: Day 1 to Day 21
proportion of initially symtomatic subjects with disappearance of clinical symptoms
Time frame: Day14 and Day 21
proportion of initially asymtomatic subjects with appearance of new clinical symptoms
Time frame: Day14 and Day 21
proportions of subjects with potentially medication- related adverse events
Time frame: 7 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Background: PubMed 31978945Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 32066525Xu Z, Li S, Tian S, Li H, Kong LQ. Full spectrum of COVID-19 severity still being depicted. Lancet. 2020 Mar 21;395(10228):947-948. doi: 10.1016/S0140-6736(20)30308-1. Epub 2020 Feb 14. No abstract available.
- Background: PubMed 32085846Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
- Background: PubMed 32075786Xu XW, Wu XX, Jiang XG, Xu KJ, Ying LJ, Ma CL, Li SB, Wang HY, Zhang S, Gao HN, Sheng JF, Cai HL, Qiu YQ, Li LJ. Clinical findings in a group of patients infected with the 2019 novel coronavirus (SARS-Cov-2) outside of Wuhan, China: retrospective case series. BMJ. 2020 Feb 19;368:m606. doi: 10.1136/bmj.m606.
- Background: PubMed 32085849Van Cuong L, Giang HTN, Linh LK, Shah J, Van Sy L, Hung TH, Reda A, Truong LN, Tien DX, Huy NT. The first Vietnamese case of COVID-19 acquired from China. Lancet Infect Dis. 2020 Apr;20(4):408-409. doi: 10.1016/S1473-3099(20)30111-0. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 32125371Wang CJ, Ng CY, Brook RH. Response to COVID-19 in Taiwan: Big Data Analytics, New Technology, and Proactive Testing. JAMA. 2020 Apr 14;323(14):1341-1342. doi: 10.1001/jama.2020.3151. No abstract available.
- Background: PubMed 32125355Adalja AA, Toner E, Inglesby TV. Priorities for the US Health Community Responding to COVID-19. JAMA. 2020 Apr 14;323(14):1343-1344. doi: 10.1001/jama.2020.3413. No abstract available.
- Background: PubMed 32188590Anderson M, Mckee M, Mossialos E. Covid-19 exposes weaknesses in European response to outbreaks. BMJ. 2020 Mar 18;368:m1075. doi: 10.1136/bmj.m1075. No abstract available.
- Background: PubMed 32113494Chatterjee P. Indian pharma threatened by COVID-19 shutdowns in China. Lancet. 2020 Feb 29;395(10225):675. doi: 10.1016/S0140-6736(20)30459-1. No abstract available.
- Background: PubMed 32165426Mahase E. Covid-19: WHO declares pandemic because of "alarming levels" of spread, severity, and inaction. BMJ. 2020 Mar 12;368:m1036. doi: 10.1136/bmj.m1036. No abstract available.
- Background: PubMed 32077901Wong JEL, Leo YS, Tan CC. COVID-19 in Singapore-Current Experience: Critical Global Issues That Require Attention and Action. JAMA. 2020 Apr 7;323(13):1243-1244. doi: 10.1001/jama.2020.2467. No abstract available.
- 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.
Tim R Harris principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxychloroquine and Azithromycin in people with Covid19, run by Hamad Medical Corporation at 1 site in Qatar.
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 3 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: finished, as of the sponsor's last update on 23 Feb 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 Qatar. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of virologically cured (PCR-negative status) as assessed on day six (time frame: Day 6). 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 NCT04349592, which also lists 37 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 23 Feb 2021.