NCT04604678

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 26, 2020

Last Update Submit

October 3, 2022

Conditions

Covid19

Keywords

metforminLDNlow dose naltrexoneCOVID-19

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Reduction in recovery time from COVID-19

    4 weeks

  • Reduction in hospitalizations

    4 weeks

  • Reduction in requirement of additional treatment due to COVID-19

    4 weeks

  • Reduction in mortality

    4 weeks

Study Arms (2)

Treatment with Metformin and LDN

EXPERIMENTAL

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

Drug: MetforminDrug: Naltrexone

Regular health care comparison group

NO INTERVENTION

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

Interventions

MetforminDRUG

Metformin at 1500 mg/day

Treatment with Metformin and LDN
NaltrexoneDRUG

Naltrexone at 4.5 mg/day (LDN)

Also known as: LDN
Treatment with Metformin and LDN

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AgelessRx

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

MetforminNaltrexone

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsNaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Sajad Zalzala, MD

    AgelessRx

    STUDY DIRECTOR

  • Sajad Zalzala, MD

    AgelessRx

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

October 27, 2020

Study Start

February 1, 2021

Primary Completion

August 1, 2021

Study Completion

October 1, 2021

Last Updated

October 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)