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

NCT ID: NCT04604678

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2021-10-31

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin at 1500 mg/day

Naltrexone

Intervention Type: DRUG

Naltrexone at 4.5 mg/day (LDN)

Regular health care comparison group

Patients will receive regular health care and will serve as a control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Metformin

Metformin at 1500 mg/day

Intervention Type: DRUG

Naltrexone

Naltrexone at 4.5 mg/day (LDN)

Intervention Type: DRUG

Other Intervention Names

LDN

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AgelessRx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sajad Zalzala, MD

Role: STUDY_DIRECTOR

AgelessRx

Sajad Zalzala, MD

Role: PRINCIPAL_INVESTIGATOR

AgelessRx

Locations

AgelessRx

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

ALRx003

Identifier Type: -

Identifier Source: org_study_id