Official Title
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
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.

Withdrawn
COVID19

Drug: Metformin

Metformin at 1500 mg/day

Drug: Naltrexone

Naltrexone at 4.5 mg/day (LDN)
Other Name: 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

Eligibility Gender
All
Eligibility Age
Minimum: 30 Years ~ Maximum: 70 Years
Countries
United States
Locations

AgelessRx
Ann Arbor, Michigan, United States

NCT Number
Keywords
metformin
LDN
low dose naltrexone
Covid-19
MeSH Terms
COVID-19
Metformin
Naltrexone