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.

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.

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).

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: AMOR 18 Powder & Inhalation; Drug: Placebo

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: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yehudit Natan; Phone Number: 08-6115024; Email: dity@amorphical.com

Study Locations

• Israel
  • Be'er Ya'aqov, Israel
    • Shamir MC
  • Tel Aviv, Israel
    • Tel-Aviv Sourasky MC
  • Tsefat, Israel
    • Ziv MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: AMOR 18 Powder & Inhalation; AMOR Inhalation x 3 times a day, via Circulaire® II AMOR Powder x 4 times a day, sublingual
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.	Drug: Placebo; Placebo Inhalation x 3 times a day, via Circulaire® II Placebo Powder x 4 times a day, sublingual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Hospital stay	Time to discharge from hospital	Date of hospitalization to treatment day 21 or discharge, whichever comes first.
Duration of ICU stay	Time patient is hospitalized in ICU, if applicable.	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
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.
Duration of Oxygen Supplementation	Time the patient requires Oxygen Supplementation (if needed)	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
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.
% 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.
% of death	Proportion of subjects died during the study, if any.	Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Frequency and severity of adverse events		Screening to End of treatment day 21 or discharge, whichever comes first.
Number and percent of patients with hypercalcemia		Treatment days 4, 7, 11, 17 and 21.

Collaborators and Investigators

• Sponsor: Amorphical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: AMCS-COVID-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No