Recruiting

Ivermectin & Doxycycline

Sponsor:

Max Health, Subsero Health

Code:

NCT04729140

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ivermectin Tablets

Doxycycline Tablets

Placebo

Study Details

Brief summary:

The purpose of this Clinical trial is to explore the therapeutic benefits of Ivermectin and Doxycycline in different combinations in high risk patients diagnosed with COVID-19.

Conditions

Covid19

Study ID

NCT04729140

Start date

Dec 28, 2020

Status verified date

Mar, 2021

Completion date

Mar 28, 2022

Anticipated

Primary completion date

Dec 28, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age greater than or equal to 18
  • Willing and able to provide verbal /telephonic/Personal or computer based Informed Consent
  • Experiencing symptoms of COVID-19 illness and tested positive for SARS CoV-2 with either PCR, NAAT or antigen testing
  • Residents in a Nursing Home or long-term care facility
  • Immunocompromised state, including solid organ transplant, HIV infection, other immune deficiency, immunosuppressant medication including systemic corticosteroids
  • Chronic lung disease, including Chronic Obstructive Pulmonary Disease (COPD), moderate to severe asthma, cystic fibrosis, pulmonary fibrosis
  • Cardiovascular Disease
  • Cancer
  • Hypertension
  • Obesity (body mass index \[BMI greater then or equal to 30 kg/m\^2\]
  • Diabetes Mellitus
  • Chronic Kidney Disease
  • Chronic Liver Disease
  • Cerebrovascular Disease
  • Neurological Disorders including dementia
  • Tobacco use disorders
  • Hematologic disorders, including sickle cell disease and thalassemia

We are also interested in including a vital population to protect, considered essential workers who may not fit into the above inclusion criteria:

  • Health care professionals and firefighters.
  • Government officials or employees.
  • Students and teachers.
  • Law enforcement agents and personnel.
  • Individuals who live with, and cannot isolate, from any of the above groups.

Exclusion Criteria:

  • Participants under the age of 18
  • Received any COVID vaccine within the last 30 days
  • Contraindications to Ivermectin or Doxycycline
  • History of Seizure Disorder or Epilepsy
  • History of Myocardial Infarction or Heart Attack within the last one month
  • Already receiving Ivermectin or Doxycycline for treatment of any other disease or disorder
  • Allergies to Ivermectin or Doxycycline including angioedema, severe asthma, exfoliative dermatitis, Steven Jonson syndrome or psoriasis
  • History of angioedema, exfoliative dermatitis, Steven Johnson syndrome, psoriasis
  • Currently Pregnant or planning to conceive soon
  • Breastfeeding
  • History of prior Clostridium Difficile infection

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ivermectin plus Doxycycline

Ivermectin 200 mcg/kg on day 1 and day 2-plus doxycycline 100 mg tablets twice a day for seven days

Body Weight (kg) Single oral Dose number of 3 mg tablets of Ivermectin

15-24 kg 1 tablet

25-35 kg 2 tablets

36-50 kg 3 tablets

51-65 kg 4 tablets

66-79 kg 5 tablets

80-109 kg 6 tablets

>110 kg 7 tablets

active comparator: Ivermectin plus Placebo

Ivermectin 200 mcg/kg on day 1 and day 2-plus placebo tablet twice a day for seven days

Body Weight (kg) Single oral Dose number of 3 mg tablets of Ivermectin and Placebo

15-24 kg 1 tablet

25-35 kg 2 tablets

36-50 kg 3 tablets

51-65 kg 4 tablets

66-79 kg 5 tablets

80-109 kg 6 tablets

>110 kg 7 tablets

placebo comparator: Placebo plus Placebo

Placebo (number of tablets according to weight) plus placebo twice a day for seven days

Body Weight (kg) Single oral Dose number of 3 mg tablets of Placebo

15-24 kg 1 tablet

25-35 kg 2 tablets

36-50 kg 3 tablets

51-65 kg 4 tablets

66-79 kg 5 tablets

80-109 kg 6 tablets

>110 kg 7 tablets

Interventions

Ivermectin Tablets

Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.

Doxycycline Tablets

Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.

Placebo

Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.

Primary outcome measure

  • Decreased admission rate to the hospital secondary to respiratory illness related to COVID-19 [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Inita Bedi

941 371 3500ibedi@mymaxdoc.com

Werther Marciales, MD

941 545 8857werther40@msn.com

Locations

MAX HEALTH, Subsero Health 2055 Wood Street, Suite 100

Recruiting

Sarasota, Florida, United States, 34237

Contacts

Inita Bedi

941-371-3500ibedi@mymaxdoc.com

Werther Marciales, MD

941 545 8857werther40@msn.com

More Information

Sponsor

Max Health, Subsero Health

Last update posted

Apr 1, 2021

Last verified

Mar, 2021

Keywords

  • COVID 19
  • Ivermectin
  • Doxycycline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Max Health, Subsero Health on 2021-04-01.