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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04604678
• Other study ID #: ALRx003
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2021
• Est. completion date: October 2021

Study information

• Verified date: October 2022
• Source: AgelessRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Metformin
Metformin at 1500 mg/day
• Naltrexone
Naltrexone at 4.5 mg/day (LDN)

Locations

Country	Name	City	State
United States	AgelessRx	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AgelessRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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