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Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) Compared to Placebo and Best Available Care (BAT), for the Treatment of Moderate to Severe COVID-19 Patients.

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: NCT04900337
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Amorphical Ltd.

Tracking Information
First Submitted Date  ICMJE May 19, 2021
First Posted Date  ICMJE May 25, 2021
Last Update Posted Date May 25, 2021
Actual Study Start Date  ICMJE February 9, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2021)		 Change of Severity rating of Disease using an 8-point ordinal scale on days 7, 14, 21, measured as improvement greater than or equal to 1 point from baseline score. [ Time Frame: Treatment Day 1 to Day 21 or discharge from hospital, the earliest. ]
Ordinal 8 points scale:
  1. Not hospitalized and no limitations of activities.
  2. Not hospitalized, with limitation of activities, home oxygen requirement, or both.
  3. Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons).
  4. Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to Covid-19 or to other medical conditions).
  5. Hospitalized, requiring any supplemental oxygen.
  6. Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices.
  7. Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
  8. Death.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2021)
  • Duration of Hospital stay [ Time Frame: Date of hospitalization to treatment day 21 or discharge, whichever comes first. ]
    Time to discharge from hospital
  • Duration of ICU stay [ Time Frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first. ]
    Time patient is hospitalized in ICU, if applicable.
  • Duration of Mechanical Ventilation Use [ Time Frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first. ]
    Time the patient requires Mechanical Ventilation (if needed)
  • Duration of Oxygen Supplementation [ Time Frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first. ]
    Time the patient requires Oxygen Supplementation (if needed)
  • Duration of No Oxygen use [ Time Frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first. ]
    Time the patient does not require Oxygen Supplementation
  • % of patients to meet ordinal scale of 3 or less [ Time Frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first. ]
    Proportion of subjects hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons).
  • % of death [ Time Frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first. ]
    Proportion of subjects died during the study, if any.
  • Frequency and severity of adverse events [ Time Frame: Screening to End of treatment day 21 or discharge, whichever comes first. ]
  • Number and percent of patients with hypercalcemia [ Time Frame: Treatment days 4, 7, 11, 17 and 21. ]
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 Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) Compared to Placebo and Best Available Care (BAT), for the Treatment of Moderate to Severe COVID-19 Patients.
Official Title  ICMJE A Phase 1/2 Prospective Randomized Placebo Controlled Study to Assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) Administered Sublingual and in Inhalation Concomitantly With BAT (Best Available Care) as Compared to Placebo and BAT for the Treatment of Moderate to Severe COVID-19 Patients.
Brief Summary This is a phase I/II study with Amorphous Calcium Carbonate (ACC) administered sublingual and in Inhalation concomitantly with BAT (Best Available Care) as Compared to Placebo and BAT for the treatment of Moderate to Severe COVID-19 patients. The purpose of this study is to assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC).
Detailed Description

This study includes two parts:

Part 1 - A training period of a single arm active treatment open label, to assess the optimal method of study drug administration, as well as the safety of the combined administration, on 5 patients.

Following DSMB review of the data collected in part 1 and the DSMB approval to proceed to next part, part 2 will be initiated.

Part 2 - A randomized (1:1) placebo controlled 2 arms study. Additional 95 patients will be recruited to this arm.

Patients who are hospitalized due to moderate or severe COVID-19 will be recruited to this study.

The following elements are the main elements that will be assessed:

  1. Confirmation SARS-CoV-2 infection
  2. Respiratory Function (breathing rate, SpO2 Oxygen Saturation
  3. Vital Signs (BP, HR), Temperature
  4. Blood Tests
  5. Disease Severity Scale (8 points ordinal scale)

The whole study period per patient will be 22 days (21 treatment days) or until the patient has recovered and/or is discharged from the hospital, whichever comes first.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: AMOR 18 Powder & Inhalation
    AMOR Inhalation x 3 times a day, via Circulaire® II AMOR Powder x 4 times a day, sublingual
  • Drug: Placebo
    Placebo Inhalation x 3 times a day, via Circulaire® II Placebo Powder x 4 times a day, sublingual
Study Arms  ICMJE
  • Experimental: AMOR 18 Powder & Inhalation

    AMOR_inhaled Double Pack- Each kit contains two tubes that after mixing result with 1.14 % ACC in 10 ml suspension.

    AMOR_powder- ACC in a dry powder (up to 2000mg Calcium/day sublingually).

    Intervention: Drug: AMOR 18 Powder & Inhalation
  • Placebo Comparator: Placebo

    Placebo_Inhaled Double Pack - Each kit contains two tubes of saline at different volumes (similar to investigational product) after mixing the results remains saline at a final volume of 10ml.

    Placebo_Powder: Each sachet contains powder at the same particle size and weight as the powder of the investigational product.

    Intervention: Drug: Placebo
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: May 23, 2021)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females of age ≥ 18 years and ≤ 80 years
  2. Signed an Informed Consent
  3. Agree to undergo blood tests as per protocol
  4. Diagnosed with COVID-19
  5. Evidence of lung involvement (by chest X rays or lung US)
  6. May or may not need for Supplemental Oxygen at enrollment
  7. Hospitalized

Exclusion Criteria:

  1. Pregnant or breast-feeding females
  2. Patients with non-COVID19 related Pneumonia
  3. Any pulmonary disease not related to COVID19
  4. Tracheostomy
  5. High flow oxygen or non-invasive ventilation (Bipap) or Mechanical ventilation
  6. Hypercalcemia defined as calcium or corrected calcium > 10.5mg/dL
  7. Hyperphosphatemia defined as > 4.5mg/dL
  8. Urine calcium to creatinine ratio >0.14
  9. Participating in another clinical study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yehudit Natan 08-6115024 dity@amorphical.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04900337
Other Study ID Numbers  ICMJE AMCS-COVID-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Amorphical Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amorphical Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Amorphical Ltd.
Verification Date April 2021

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