Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Combination Therapy to Treat COVID-19 Infection

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04482686
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : May 14, 2021
Sponsor:
Collaborator:
Topelia Therapeutics
Information provided by (Responsible Party):
ProgenaBiome

Tracking Information
First Submitted Date  ICMJE July 21, 2020
First Posted Date  ICMJE July 22, 2020
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE December 9, 2020
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
  • Time to Non-Infectivity by RT-PCR [ Time Frame: 6 months ]
    Time to negative RT-PRC result indicating that patient is no longer infective
  • Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score) [ Time Frame: 6 months ]
    Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
  • Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score) [ Time Frame: 6 months ]
    Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
  • Efficacy of Treatment as measured by Titer [ Time Frame: 6 months ]
    Patients will have serum stored for titer testing to compare antibody levels over time
  • Efficacy of Treatment as measured by RT-PCR [ Time Frame: 10 days ]
    Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
  • Safety of Treatment as Measured by D-Dimer [ Time Frame: 6 Months ]
    Blood D-Dimer levels
  • Safety of Treatment as Measured by Pro-Calcitonin [ Time Frame: 6 Months ]
    Blood Pro-Calcitonin levels
  • Safety of Treatment as Measured by C-Reactive Protein [ Time Frame: 6 Months ]
    Blood CRP levels
  • Safety of Treatment as Measured by Ferritin [ Time Frame: 6 Months ]
    Blood ferritin levels
  • Safety of Treatment as Measured by Liver Enzymes [ Time Frame: 6 Months ]
    Blood enzyme levels
  • Safety of Treatment as Measured by Complete Blood Count [ Time Frame: 6 Months ]
    CBC
  • Safety of Treatment as Measured by Electrolyte Levels [ Time Frame: 6 Months ]
    Blood electrolytes
  • Safety of Treatment as Measured by Treatment Related Adverse Events [ Time Frame: 6 months ]
    Presence or absence of Grade 3 or high treatment related adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Combination Therapy to Treat COVID-19 Infection
Official Title  ICMJE A Phase II Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection
Brief Summary In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Detailed Description Patients in this trial will undergo treatment for 10 days with either a combination of therapies or placebo. They will then be followed for an additional 20 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID
  • Covid-19
  • Corona Virus Infection
  • Coronavirus Infection
  • Coronavirus-19
  • SARS-CoV2
  • SARS-CoV Infection
Intervention  ICMJE
  • Drug: Ivermectin
    Treatment days 1, 4, and 8
    Other Name: Soolantra, Stromectol, Sklice
  • Drug: Doxycycline Hcl
    10 day treatment
    Other Name: Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory
  • Dietary Supplement: Zinc
    10 Day treatment
    Other Name: Zinc sulphate
  • Dietary Supplement: Vitamin D3
    10 day treatment
    Other Name: cholecalciferol-D3
  • Dietary Supplement: Vitamin C
    10 day treatment
    Other Name: L-ascorbic acid
Study Arms  ICMJE
  • Experimental: Active Arm
    Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
    Interventions:
    • Drug: Ivermectin
    • Drug: Doxycycline Hcl
    • Dietary Supplement: Zinc
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Vitamin C
  • Placebo Comparator: Placebo
    Placebo and Vitamin D3, Vitamin C, and Zinc
    Interventions:
    • Dietary Supplement: Zinc
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Vitamin C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 14, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2020)
300
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
  2. Healthy male or female subjects 18 years of age to 75 years of age
  3. Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization will be stratified.
  4. Positive test for COVID-19 by RT-PCR at screening
  5. Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. One of these must be a barrier method. Exceptions for females and partners of females that are not of childbearing potential. (e.g. surgically sterilized, post-menopausal)
  6. Subjects must agree they will attend the treatment facility daily for 10d in the event of failure to attend, the patient will be visited at their home to collect the nasal swab and review data.

Exclusion Criteria:

  1. Refusal to sign informed consent form
  2. Negative test for COVID-19 by RT-PCR at screening
  3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnoea, shortness of breath, temperature > 38 degrees C (100.4 degrees F), pleuritic pain, or frequent cough.
  4. Known drug allergy to any of the investigational medications
  5. Currently taking medication with known drug interactions with investigational medications, found in Appendix II
  6. Prescription or other antiviral medications
  7. Any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine
  8. Inability to attend daily for 10 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Borody, MD +61-2-9713 4011 RECEPTION@CDD.COM.AU
Contact: Jordan Daniels, MS 805-339-0549 jordan@progenabiome.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04482686
Other Study ID Numbers  ICMJE PRG-049
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ProgenaBiome
Study Sponsor  ICMJE ProgenaBiome
Collaborators  ICMJE Topelia Therapeutics
Investigators  ICMJE
Study Director: Sabine Hazan, MD ProgenaBiome
Study Director: Thomas Borody, MD Topelia Therpeutics
PRS Account ProgenaBiome
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP