Covid19Phase 2NCT04604678
Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19
A Phase 2 study testing Metformin and Naltrexone in people with Covid19, run by AgelessRx at 1 site in United States.
Trial summary
Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- Metformin and Naltrexone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2021to Oct 2021
- Phase
- Phase 2
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-70
- Any sex
- Any ethnicity
- Adequate cognitive function to be able to give informed consent
- Technologically competent to complete web forms and perform video calls with the PI
- Positive PCR (polymerase chain reaction) test result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) within the last 10 days
Show all 9Show fewer
- At least two COVID-19 symptoms as assessed by laboratory or patient self-reporting started within the last 3 days
- Willing to fill out regular questionnaires
- Willing to take metformin and LDN
Who cannot join
- Clinically significant hepatic, renal, or cardiac impairment (as determined by previous clinical judgement)
- Hypoglycemia
- Currently on drugs for COVID-19
- Hospitalization for COVID-19
- (Suspected) pregnancy or breastfeeding
- Active cancer
Show all 12Show fewer
- Uncontrolled mental health issues
- On any medication with major interactions with metformin or LDN
- Taking opioid analgesics, or being treated for opioid addiction/recovery
- Opioid dependence or withdrawal syndrome
- Known sensitivity to metformin or naltrexone
- Current users of metformin or naltrexone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Into the Use of Metformin and Low Dose Naltrexone (LDN) for Patients With Coronavirus Disease 2019 (COVID-19) - Assessment of Short and Long Term Effects
Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.
Read the detailed description
The researchers will treat 40 patients with metformin (1500 mg/day) and LDN (4.5 mg/day) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19. These 40 patients will be compared with 40 control patients who will receive regular care. All patients will be asked to complete surveys at baseline and after 1, 2, and 4 weeks after initiation of treatment. The difference with baseline at each time point will be assessed. The surveys will assess COVID-19 symptoms severity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin at 1500 mg/day
NaltrexoneDrug
Also called LDN
Naltrexone at 4.5 mg/day (LDN)
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Metformin and LDN | Experimental | Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks. Receives: Drug: Metformin; Drug: Naltrexone |
| Regular health care comparison group | No intervention | Patients will receive regular health care and will serve as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN
Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'.
Measured: 1 week
Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN
Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'.
Measured: 2 weeks
Secondary outcomes (4)
Reduction in recovery time from COVID-19
Reduction in the number of days with symptoms due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Measured: 4 weeks
Reduction in hospitalizations
Reduction in the number of patients being hospitalized due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Measured: 4 weeks
Reduction in requirement of additional treatment due to COVID-19
Reduction in the number of patients requiring additional treatment for COVID-19 upon treatment with metformin and LDN, compared to placebo group
Measured: 4 weeks
Reduction in mortality
Reduction in the number of mortality cases due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study startFeb 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: Unable to recruit participants due to restrictive inclusion/exclusion criteria. Will update protocol with IRB \& begin anew after approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgelessRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sajad Zalzala, MD, Study director, AgelessRxSajad Zalzala, MD, Principal investigator, AgelessRx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604678
- Sponsor's protocol ID
- ALRx003
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Into the Use of Metformin and Low Dose Naltrexone (LDN) for Patients With Coronavirus Disease 2019 (COVID-19) - Assessment of Short and Long Term Effects
- ClinicalTrials.gov ID
- NCT04604678
- Acronym / sponsor ID
- ALRx003
- Conditions
- Covid19
- Keywords
- metformin, LDN, low dose naltrexone, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants due to restrictive inclusion/exclusion criteria. Will update protocol with IRB \& begin anew after approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AgelessRxIndustry (pharma, biotech, devices)
- Study start
- Feb 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 27 Oct 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.
Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.
Detailed description
The researchers will treat 40 patients with metformin (1500 mg/day) and LDN (4.5 mg/day) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19. These 40 patients will be compared with 40 control patients who will receive regular care. All patients will be asked to complete surveys at baseline and after 1, 2, and 4 weeks after initiation of treatment. The difference with baseline at each time point will be assessed. The surveys will assess COVID-19 symptoms severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Metformin and LDN | Experimental | Drug: Metformin, Drug: NaltrexonePatients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks. |
| Regular health care comparison group | No intervention | –Patients will receive regular health care and will serve as a control group. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 30-70
- Any sex
- Any ethnicity
- Adequate cognitive function to be able to give informed consent
- Technologically competent to complete web forms and perform video calls with the PI
Key exclusion criteria (12 listed)
- Clinically significant hepatic, renal, or cardiac impairment (as determined by previous clinical judgement)
- Hypoglycemia
- Currently on drugs for COVID-19
- Hospitalization for COVID-19
- (Suspected) pregnancy or breastfeeding
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 |
|---|---|---|
| MetforminMetformin at 1500 mg/day | Drug | Treatment with Metformin and LDN |
| NaltrexoneAlso: LDNNaltrexone at 4.5 mg/day (LDN) | Drug | Treatment with Metformin and LDN |
Primary outcome
Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN
Time frame: 1 week
Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'.
Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN
Time frame: 2 weeks
Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'.
4 secondary outcomes
Reduction in recovery time from COVID-19
Time frame: 4 weeks
Reduction in hospitalizations
Time frame: 4 weeks
Reduction in requirement of additional treatment due to COVID-19
Time frame: 4 weeks
Reduction in mortality
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- 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.
Sajad Zalzala, MD study director
AgelessRx
Sajad Zalzala, MD principal investigator
AgelessRx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and Naltrexone in people with Covid19, run by AgelessRx 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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 4 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN (time frame: 1 week). 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?
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 4 Oct 2022.