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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04604678
Recruitment Status : Withdrawn (Unable to recruit participants due to restrictive inclusion/exclusion criteria. Will update protocol with IRB & begin anew after approval.)
First Posted : October 27, 2020
Last Update Posted : October 4, 2022
Sponsor:
Information provided by (Responsible Party):
AgelessRx

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Metformin Drug: Naltrexone Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Metformin
Metformin at 1500 mg/day

Drug: Naltrexone
Naltrexone at 4.5 mg/day (LDN)
Other Name: LDN
No Intervention: Regular health care comparison group
Patients will receive regular health care and will serve as a control group.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN [ Time Frame: 1 week ]
    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. Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN [ Time Frame: 2 weeks ]
    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'.


Secondary Outcome Measures :
  1. Reduction in recovery time from COVID-19 [ Time Frame: 4 weeks ]
    Reduction in the number of days with symptoms due to COVID-19 upon treatment with metformin and LDN, compared to placebo group

  2. Reduction in hospitalizations [ Time Frame: 4 weeks ]
    Reduction in the number of patients being hospitalized due to COVID-19 upon treatment with metformin and LDN, compared to placebo group

  3. Reduction in requirement of additional treatment due to COVID-19 [ Time Frame: 4 weeks ]
    Reduction in the number of patients requiring additional treatment for COVID-19 upon treatment with metformin and LDN, compared to placebo group

  4. Reduction in mortality [ Time Frame: 4 weeks ]
    Reduction in the number of mortality cases due to COVID-19 upon treatment with metformin and LDN, compared to placebo group


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604678


Locations
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United States, Michigan
AgelessRx
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
AgelessRx
Investigators
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Study Director: Sajad Zalzala, MD AgelessRx
Principal Investigator: Sajad Zalzala, MD AgelessRx
More Information
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Responsible Party: AgelessRx
ClinicalTrials.gov Identifier: NCT04604678    
Other Study ID Numbers: ALRx003
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AgelessRx:
metformin
LDN
low dose naltrexone
COVID-19
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Metformin
Naltrexone
Hypoglycemic Agents
Physiological Effects of Drugs
Alcohol Deterrents
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents