Clinical trial NCT04604678: Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Covid19
Keywords: metformin
LDN
low dose naltrexone
COVID-19
Lead sponsor: AgelessRx
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN
timeFrame: 1 week
measure: Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN
timeFrame: 2 weeks
Secondary outcomes:
measure: Reduction in recovery time from COVID-19
timeFrame: 4 weeks
measure: Reduction in hospitalizations
timeFrame: 4 weeks
measure: Reduction in requirement of additional treatment due to COVID-19
timeFrame: 4 weeks
measure: Reduction in mortality
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: AgelessRx
state: Michigan
Study officials:
affiliation: AgelessRx
name: Sajad Zalzala, MD
role: STUDY_DIRECTOR
affiliation: AgelessRx
name: Sajad Zalzala, MD
role: PRINCIPAL_INVESTIGATOR
References: