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.

NCT04900337 | Completed Phase 1 DMC

• 1 other identifier: AMCS-COVID-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

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).

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  Treatment Day 1 to Day 21 or discharge from hospital, the earliest.

Secondary Outcomes (9)

• Duration of Hospital stay

  Date of hospitalization to treatment day 21 or discharge, whichever comes first.

• Duration of ICU stay

  Treatment Day 1 to treatment day 21 or discharge, whichever comes first.

• Duration of Mechanical Ventilation Use

  Treatment Day 1 to treatment day 21 or discharge, whichever comes first.

• Duration of Oxygen Supplementation

  Treatment Day 1 to treatment day 21 or discharge, whichever comes first.

• Duration of No Oxygen use

  Treatment Day 1 to treatment day 21 or discharge, whichever comes first.

Study Arms (2)

AMOR 18 Powder & Inhalation

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

AMOR 18 Powder & Inhalation DRUG

AMOR Inhalation x 3 times a day, via Circulaire® II AMOR Powder x 4 times a day, sublingual

AMOR 18 Powder & Inhalation

Placebo DRUG

Placebo Inhalation x 3 times a day, via Circulaire® II Placebo Powder x 4 times a day, sublingual

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or breast-feeding females
• Patients with non-COVID19 related Pneumonia
• Any pulmonary disease not related to COVID19
• Tracheostomy
• High flow oxygen or non-invasive ventilation (Bipap) or Mechanical ventilation
• Hypercalcemia defined as calcium or corrected calcium \> 10.5mg/dL
• Hyperphosphatemia defined as \> 4.5mg/dL
• Urine calcium to creatinine ratio \>0.14
• Participating in another clinical study

Sponsors & Collaborators

• Amorphical Ltd.: lead

Study Sites (3)

Shamir MC

Be’er Ya‘aqov, Israel

Location

Ziv MC

Safed, Israel

Location

Tel-Aviv Sourasky MC

Tel Aviv, Israel

Location

MeSH Terms

Conditions

COVID-19

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: February 9, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

IL (3)