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

AgelessRx

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Covid19

Interventions

MetforminDRUG

Metformin at 1500 mg/day

NaltrexoneDRUG

Naltrexone at 4.5 mg/day (LDN)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

AgelessRx

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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'.

Time frame: 1 week

Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN

Time frame: 2 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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