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

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid19
• Intervention / Treatment: Drug: Metformin; Drug: Naltrexone

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • AgelessRx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Metformin and LDN; 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; Metformin at 1500 mg/day; Drug: Naltrexone; Naltrexone at 4.5 mg/day (LDN); Other Names: LDN
No Intervention: Regular health care comparison group; Patients will receive regular health care and will serve as a control group.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AgelessRx
• Investigators: Study Director: Sajad Zalzala, MD, AgelessRx; Principal Investigator: Sajad Zalzala, MD, AgelessRx

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; metformin; low dose naltrexone; LDN
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Hypoglycemic Agents; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone; Metformin
• Other Study ID Numbers: ALRx003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No