SARS-CoV-2Phase 3VA-REACHNCT04363203
VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)
A Phase 3 study testing Hydroxychloroquine and Azithromycin in people with SARS-CoV-2 and COVID-19, run by Salomeh Keyhani MD at 1 site in United States.
Trial summary
We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting. Read more about this study
- Who is it for?
- Ages 216 months and older
- Conditions the study is for
- SARS-CoV-2, COVID-19
- 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
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2020to Aug 2021
- Phase
- Phase 3
- 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 216 months and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willingness to take the study drug and ability to take oral medications
- able to be contacted by phone
- willing and able to give informed consent for participation in the study and agrees with its conduct and willing to email the study team a picture of their consent form
Who cannot join
- We will exclude individuals based on the following national VA data and chart review criteria:
- eGFR <30mL/min or dialysis
- aspartate transaminase (AST) or alanine transaminase (ALT) >5 times the upper limit of normal or cirrhosis in past 2 years
- hypersensitivity to chloroquine, hydroxychloroquine or other 4-aminoquinolines (e.g., amodiaquine), azithromycin or macrolides
- already taking hydroxychloroquine or azithromycin
- congestive heart failure with an ejection fraction (EF) <35% in past 2 years or hospitalization within past 6 months
Show all 21Show fewer
- concomitant treatment with any QT prolonging drug
- history of cardiac arrest, ventricular fibrillation or ventricular tachycardia in past 5 years
- QT prolongation on any ECG in past 5 years
- potassium <3.5 meq/l in labs in past 2 years
- magnesium< 1/5 meq/l in any lab in past 2 years
- any patient who has not had follow-up with their primary care doctors in past 2 years
- any Veteran who cannot follow-up such as those with dementia, home based primary care or those with active psychosis documented in past 2 years
- G6PD deficiency
- Exclusions Based on Baseline Interview:
- any female who is breastfeeding or pregnant or planning to become pregnant.
- any Veteran who receives most of their care in non-VA settings
- Veteran enrolled in another COVID Trial
- Veteran received a prescription for azithromycin and hydroxychloroquine
- Veteran allergic to azithromycin and or hydroxychloroquine
- Veteran receiving QT prolonging drugs from non-VA pharmacy
Trial locations and contacts
1 site in 1 country.
About this study
We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.
Read the detailed description
SARS-CoV-2 is a novel coronavirus disease (COVID-19) that presents with fever, cough, and shortness of breath, and has a mortality rate of 2-4%. Outcomes are worse among the elderly and those with cardiovascular, respiratory, cancer and other co-morbidities. Several treatments are also emerging as promising therapeutic candidates, hydroxychloroquine and azithromycin - both available as generic pills and widely used for other indications - are potential options for treatment. A small randomized controlled trial (RCT) of hospitalized patients suggests chloroquine may be superior to placebo in promoting viral elimination and shortening disease course. Hydroxychloroquine is preferred to chloroquine in the U.S. A small non-randomized trial found azithromycin had a clinical benefit. When azithromycin and hydroxychloroquine are given together, they can cause cardiac side-effects that limit use in the outpatient setting. These drugs, however, have independent potential benefits against COVID-19 that require more rigorous study before either is considered standard of care. We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.
- Conditions
- SARS-CoV-2, COVID-19
- Being tested
- Hydroxychloroquine, Azithromycin, Placebo oral tablet
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine: 2x200mg mg .PO in the AM and 2x200mg PO in the PM on Day 1, followed by 200mg PO in the AM and 200 mg PO in the PM on Days 2-5.
AzithromycinDrug
Azithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5.
Placebo oral tabletDrug
Placebo in pill packs identical to study drugs
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Active comparator | Hydroxychloroquine: 2x200mg mg PO in the AM and 2x200mg PO in the PM on Day 1, followed by 200mg capsule in the AM and 200 mg in the PM on Days 2-5 Receives: Drug: Hydroxychloroquine |
| Azithromycin | Active comparator | Azithromycin: 2x250mg by mouth (PO) in the AM followed by 250mg PO every day on days 2-5 Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | The pills packs for the 3 arms are identical. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to resolution of cough, fever and shortness of breath
Measured: 30-days
Secondary outcomes (5)
Days to resolution of all COVID-19 symptoms
Measured: 30-days
All cause hospitalization
Measured: 30-days
All cause mortality
Measured: 30-days
COVID-19 specific mortality
Measured: 30-days
COVID-19 specific hospitalization
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start30 Apr 2020
- Primary completionMar 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: concerns related to study drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin compared to placebo in treating mild to moderate COVID-19 among Veterans in the outpatient setting.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salomeh Keyhani MD
- Sponsor type
- US federal agency
- Collaborators
- San Francisco VA Health Care System
- Responsible party
- Sponsor-investigator, Salomeh Keyhani MD, San Francisco VA Health Care System
- Investigators
- Salomeh Keyhani, MD MPH, Principal investigator, San Francisco VA/University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363203
- Sponsor's protocol ID
- 20-30517
- Acronym
- VA-REACH
- Status last verified
- Jun 2020
- First submitted
- 23 Apr 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keyhani S, Kelly JD, Bent S, Boscardin WJ, Shlipak MG, Leonard S, Abraham A, Lum E, Lau N, Austin C, Oldenburg CE, Zillich A, Lopez L, Zhang Y, Lietman T, Bravata DM. A telehealth-based randomized controlled trial: A model for outpatient trials of off-label medications during the COVID-19 pandemic. Clin Trials. 2021 Aug;18(4):514-517. doi: 10.1177/17407745211011577. Epub 2021 May 20.
PubMed 34011199
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)
- ClinicalTrials.gov ID
- NCT04363203
- Acronym / sponsor ID
- VA-REACH / 20-30517
- Conditions
- SARS-CoV-2, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: concerns related to study drug
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Salomeh Keyhani MDUS federal agency
- Collaborators
- San Francisco VA Health Care System
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 27 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.
We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.
Detailed description
SARS-CoV-2 is a novel coronavirus disease (COVID-19) that presents with fever, cough, and shortness of breath, and has a mortality rate of 2-4%. Outcomes are worse among the elderly and those with cardiovascular, respiratory, cancer and other co-morbidities. Several treatments are also emerging as promising therapeutic candidates, hydroxychloroquine and azithromycin - both available as generic pills and widely used for other indications - are potential options for treatment. A small randomized controlled trial (RCT) of hospitalized patients suggests chloroquine may be superior to placebo in promoting viral elimination and shortening disease course. Hydroxychloroquine is preferred to chloroquine in the U.S. A small non-randomized trial found azithromycin had a clinical benefit. When azithromycin and hydroxychloroquine are given together, they can cause cardiac side-effects that limit use in the outpatient setting. These drugs, however, have independent potential benefits against COVID-19 that require more rigorous study before either is considered standard of care. We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin compared to placebo in treating mild to moderate COVID-19 among Veterans in the outpatient setting.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Active comparator | Drug: HydroxychloroquineHydroxychloroquine: 2x200mg mg PO in the AM and 2x200mg PO in the PM on Day 1, followed by 200mg capsule in the AM and 200 mg in the PM on Days 2-5 |
| Azithromycin | Active comparator | Drug: AzithromycinAzithromycin: 2x250mg by mouth (PO) in the AM followed by 250mg PO every day on days 2-5 |
| Placebo | Placebo comparator | Drug: Placebo oral tabletThe pills packs for the 3 arms are identical. |
Who may qualify
- Ages
- 216 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- willingness to take the study drug and ability to take oral medications
- able to be contacted by phone
- willing and able to give informed consent for participation in the study and agrees with its conduct and willing to email the study team a picture of their consent form
Key exclusion criteria (21 listed)
- We will exclude individuals based on the following national VA data and chart review criteria:
- eGFR <30mL/min or dialysis
- aspartate transaminase (AST) or alanine transaminase (ALT) >5 times the upper limit of normal or cirrhosis in past 2 years
- hypersensitivity to chloroquine, hydroxychloroquine or other 4-aminoquinolines (e.g., amodiaquine), azithromycin or macrolides
- already taking hydroxychloroquine or azithromycin
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 |
|---|---|---|
| HydroxychloroquineHydroxychloroquine: 2x200mg mg .PO in the AM and 2x200mg PO in the PM on Day 1, followed by 200mg PO in the AM and 200 mg PO in the PM on Days 2-5. | Drug | Hydroxychloroquine |
| AzithromycinAzithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5. | Drug | Azithromycin |
| Placebo oral tabletPlacebo in pill packs identical to study drugs | Drug | Placebo |
Primary outcome
Days to resolution of cough, fever and shortness of breath
Time frame: 30-days
5 secondary outcomes
Days to resolution of all COVID-19 symptoms
Time frame: 30-days
All cause hospitalization
Time frame: 30-days
All cause mortality
Time frame: 30-days
COVID-19 specific mortality
Time frame: 30-days
COVID-19 specific hospitalization
Time frame: 30-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Derived from this study: PubMed 34011199Keyhani S, Kelly JD, Bent S, Boscardin WJ, Shlipak MG, Leonard S, Abraham A, Lum E, Lau N, Austin C, Oldenburg CE, Zillich A, Lopez L, Zhang Y, Lietman T, Bravata DM. A telehealth-based randomized controlled trial: A model for outpatient trials of off-label medications during the COVID-19 pandemic. Clin Trials. 2021 Aug;18(4):514-517. doi: 10.1177/17407745211011577. Epub 2021 May 20.
- Individual participant dataSharing planned: No
Related trials for SARS-CoV-2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
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
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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
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.
Salomeh Keyhani, MD MPH principal investigator
San Francisco VA/University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine and Azithromycin in people with SARS-CoV-2 and COVID-19, run by Salomeh Keyhani MD 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 3 inclusion and 21 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: paused, as of the sponsor's last update on 22 Jun 2020. 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 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?
Results are not available in the source record.
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?
Days to resolution of cough, fever and shortness of breath (time frame: 30-days). 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 NCT04363203, which also lists 1 linked publication.
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 22 Jun 2020.