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.

Phase 1

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
AMOR 18 Powder & Inhalation	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).
Placebo	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.

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Oxygen Supplementation	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.	Time the patient requires Oxygen Supplementation (if needed)
Frequency and severity of adverse events	Screening to End of treatment day 21 or discharge, whichever comes first.
% of death	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.	Proportion of subjects died during the study, if any.
Number and percent of patients with hypercalcemia	Treatment days 4, 7, 11, 17 and 21.
Duration of Hospital stay	Date of hospitalization to treatment day 21 or discharge, whichever comes first.	Time to discharge from hospital
Duration of ICU stay	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	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.	Time the patient requires Mechanical Ventilation (if needed)
Duration of No Oxygen use	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	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).

Locations (3): Ziv MC
🇮🇱
Tsefat, Israel
Tel-Aviv Sourasky MC
🇮🇱
Tel Aviv, Israel
Shamir MC
🇮🇱
Be'er Ya'aqov, Israel