Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Drug: Metformin
* Drug: Naltrexone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Metformin and LDN<br>Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks. | Drug: Metformin<br>* Metformin at 1500 mg/day<br>Drug: Naltrexone<br>* Naltrexone at 4.5 mg/day (LDN)<br>* Other names: LDN;|
| No Intervention: Regular health care comparison group<br>Patients will receive regular health care and will serve as a control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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'. | 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'. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metformin, LDN, low dose naltrexone, COVID-19