A Study to Evaluate the Safety and Efficacy of Artemisinin- a Herbal Supplement on COVID-19 Subjects

September 1, 2021 updated by: Mateon Therapeutics

A Prospective, Randomized, Multi-center, Open Label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg Capsule in Treatment of Adult Subjects With COVID-19

This will be an open label, prospective, multi-center, comparative, interventional study to evaluate safety and efficacy of Artemisinin 500 mg in subjects with mild to moderate COVID-19. Initially subjects having mild to moderate COVID-19 will be screened as per predefined eligibility criteria for the study. Eligible 120 subjects will be enrolled to receive treatment with Artemisinin and SOC (Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)) or SOC. Subjects will be randomized in 2:1 ratio. Group 1 will have 80 subjects and Group 2 will have 40 subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will involve screening (Day 1), treatment period of up to maximum 28 days till end of study. The investigator shall make every effort to follow the schedule of study assessments and procedures. A window period of 1 day will be allowed for assessments post randomization. Screening Upon obtaining the written informed consent the subjects will be screened to confirm the eligibility for participating in this study. If RT PCR result is available for the subject then screening and baseline (randomization) activity will be on the same day. As per the Investigator discretion, the subjects meeting the criteria will be hospitalized for the first cycle of treatment Treatment period Subjects will receive investigational product and SOC after randomization as per protocol. Subject's compliance with the study treatment regimen of Artemisinin one (1) capsule a day for five (5) days, will be assessed during treatment period. Subjects receiving at least one dose of study treatment will be included in the safety analysis. Efficacy analysis will be conducted in completers (subjects who have completed at least 5 consecutive days of dosing in either arm) The first cycle of the study drug treatment will be given in the hospital, for which the subjects have to be hospitalized till Day 5, unless prolongation of hospital stay is necessary as per the investigator. On day 14, telephonic follow up is done for subjects discharged after Day 5. For Day 28 visit all subjects will visit the hospital to complete the End of Study activities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Srikakulam, Andhra Pradesh, India, 532001
        • Government Medical College & Government General Hospital, Srikakulam
    • Maharashtra
      • Kolhapur, Maharashtra, India, 431001
        • Rajarshi Chhatrapati Shahu Maharaj Government Medical college and Chhatrapati Pramila Raje Hospital
      • Nagpur, Maharashtra, India, 440009
        • Seven Star Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects of ≥18 to 60 years of age both inclusive
  2. Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  3. Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-19. Scores of 2-4 on the WHO Clinical Progression Scale
  4. Time interval between symptoms onset and randomization of no more than 7 days

  5. One or more of the following symptoms:

    Fever Cough Sore throat Headache Nasal congestion Malaise Diarrhea Loss of smell Loss of taste

  6. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

Exclusion Criteria:

  1. Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening
  2. Known or suspected hypersensitivity to Artemisinin
  3. Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
  4. Men who are unwilling to use contraception while receiving investigational product
  5. Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol
  6. Subjects with history of severe renal and hepatic impairment. (creatine ≥2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN)
  7. Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days
  8. Known history of failure to control systemic fungal, bacterial or viral infection
  9. Patients with the history of following co-morbidities: diabetes, hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome
  10. Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection
  11. Have a history of neurological or psychiatric disorders, including epilepsy or dementia
  12. Subjects for whom ventilator support is required at screening
  13. Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19
  14. Subjects not willing to give their informed consent to participate in the clinical trial
  15. According to the investigator judgment there are concomitant diseases with a serious safety hazard or affect the subject
  16. Using other experimental drugs or participating in other clinical trials in the prior one month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Artemisinin 500mg
The dose regimen will be in cycles. In a cycle a subject will receive Artemisinin 500 mg capsule once daily plus SOC on Day 1 to Day 5 followed by 5 days off (no dosing of Artemisinin) or SOC alone. A subject can have a total of consecutive 3 cycles maximum. Here SOC is Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)
Dietary supplement: Artemisinin
a herbal supplement
Active Comparator: Standard of Care
Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division) Mild Patients: HYDROXYCHLOROQUINE Moderate Patients: Dexamethasone - OD for 05
Drug: Dexamethasone
corticosteroids

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Assessments
Time Frame: 28 days
  • Incidence of adverse events during the study.
  • Incidence of serious adverse events during the study.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy Assessments
Time Frame: 28 days
  • Improvement rate in severity of COVID-19 per 8-point WHO COVID-19 Clinical Improvement Ordinal Scale.
  • Improvement rate in severity of COVID-19 per the Duration of Symptoms.

Clinical improvement is defined as

• A rate decrease to categories 1, 2, 3, or 4.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mateon Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Windlas Biotech Private Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mukesh Kumar, Windlas Biotech Private Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Trieu V, Saund S, Rahate PV, Barge VB, Nalk KS, Windlass H, Uckun FM. Targeting TGF-beta pathway with COVID-19 Drug Candidate ARTIVeda/PulmoHeal Accelerates Recovery from Mild-Moderate COVID-19. Clinical Investigation (2021) 11(1), 10-18

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARTI/WBPL/P4/2020/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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