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

AgelessRx

Status and phase: Withdrawn; Phase 2

Conditions: Covid19

Treatments: Drug: Naltrexone; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04604678

ALRx003

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Treatment with Metformin and LDN

Experimental group

Description:

Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.

Treatment:

Drug: Metformin

Drug: Naltrexone

Regular health care comparison group

No Intervention group

Description:

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