NCT04900337

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Amorphical Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-09
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-05-25
• Last updated: 2024-02-28

Locations

3 sites across 1 country: Israel