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.

Covid19 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04900337
• Other study ID #: AMCS-COVID-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 9, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Amorphical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• AMOR 18 Powder & Inhalation
AMOR Inhalation x 3 times a day, via Circulaire® II AMOR Powder x 4 times a day, sublingual
• Placebo
Placebo Inhalation x 3 times a day, via Circulaire® II Placebo Powder x 4 times a day, sublingual

Locations

Country	Name	City	State
Israel	Shamir MC	Be'er Ya'aqov
Israel	Tel-Aviv Sourasky MC	Tel Aviv
Israel	Ziv MC	Tsefat

Sponsors (1)

Lead Sponsor	Collaborator
Amorphical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Ordinal 8 points scale: Not hospitalized and no limitations of activities.; Not hospitalized, with limitation of activities, home oxygen requirement, or both.; Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons).; Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to Covid-19 or to other medical conditions).; Hospitalized, requiring any supplemental oxygen.; Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices.; Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).; Death.	Treatment Day 1 to Day 21 or discharge from hospital, the earliest.
Secondary	Duration of Hospital stay	Time to discharge from hospital	Date of hospitalization to treatment day 21 or discharge, whichever comes first.
Secondary	Duration of ICU stay	Time patient is hospitalized in ICU, if applicable.	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Secondary	Duration of Mechanical Ventilation Use	Time the patient requires Mechanical Ventilation (if needed)	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Secondary	Duration of Oxygen Supplementation	Time the patient requires Oxygen Supplementation (if needed)	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Secondary	Duration of No Oxygen use	Time the patient does not require Oxygen Supplementation	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Secondary	% of patients to meet ordinal scale of 3 or less	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).	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Secondary	% of death	Proportion of subjects died during the study, if any.	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Secondary	Frequency and severity of adverse events		Screening to End of treatment day 21 or discharge, whichever comes first.
Secondary	Number and percent of patients with hypercalcemia		Treatment days 4, 7, 11, 17 and 21.