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Novel Agents for Treatment of High-risk COVID-19 Positive Patients

NCT04374019 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-01-20

Study results available
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Summary

This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone or combination treatment with hydroxychloroquine, azithromycin, ivermectin, or camostat mesilate, artemesia annua. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus replication in will be devoid of additional moderate to severe toxicities, will prevent clinical deterioration, and will improve viral clearance in high risk individuals.

Conditions

Interventions

DRUG

Ivermectin

Ivermectin: Days 1-2: Weight \< 75kg: 4 tabs (12 mg total daily dose) Days 1-2: Weight \> 75kg: 5 tabs (15 mg total daily dose)

DRUG

Camostat Mesilate

Days 1-14: 2 tab TID after a meal (600 mg total daily dose)

DIETARY_SUPPLEMENT

Artemesia annua

Days 1-14: tea or coffee pod TID (1350 mg total daily dose)

DRUG

Artesunate

Days 1-14:

Sponsors & Collaborators

  • Susanne Arnold

    lead OTHER

Principal Investigators

  • Susanne Arnold, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2020-12-21
Completion
2022-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04374019 on ClinicalTrials.gov