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

Phase 2

Withdrawn

• Conditions: Covid19
• Interventions: Drug: Metformin; Drug: Naltrexone

• Registration Number: NCT04604678
• Lead Sponsor: AgelessRx

Brief 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.

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 Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-27
• Study Start: 2021-02
• Primary Completion: 2021-08
• Study Completion: 2021-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Metformin and LDN	Metformin	Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.
Treatment with Metformin and LDN	Naltrexone	Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.

Primary Outcome Measures

Name	Time	Method
Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN	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	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'.

Secondary Outcome Measures

Name	Time	Method
Reduction in mortality	4 weeks	Reduction in the number of mortality cases due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Reduction in recovery time from COVID-19	4 weeks	Reduction in the number of days with symptoms due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Reduction in hospitalizations	4 weeks	Reduction in the number of patients being hospitalized due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Reduction in requirement of additional treatment due to COVID-19	4 weeks	Reduction in the number of patients requiring additional treatment for COVID-19 upon treatment with metformin and LDN, compared to placebo group

Trial Locations

Locations (1)

AgelessRx; 🇺🇸 Ann Arbor, Michigan, United States