Clinical trial 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Covid19
Lead sponsor: Amorphical Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Treatment Day 1 to Day 21 or discharge from hospital, the earliest.
Secondary outcomes:
measure: Duration of Hospital stay
timeFrame: Date of hospitalization to treatment day 21 or discharge, whichever comes first.
measure: Duration of ICU stay
timeFrame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
measure: Duration of Mechanical Ventilation Use
timeFrame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
measure: Duration of Oxygen Supplementation
timeFrame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
measure: Duration of No Oxygen use
timeFrame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
measure: % of patients to meet ordinal scale of 3 or less
timeFrame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
measure: % of death
timeFrame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
measure: Frequency and severity of adverse events
timeFrame: Screening to End of treatment day 21 or discharge, whichever comes first.
measure: Number and percent of patients with hypercalcemia
timeFrame: Treatment days 4, 7, 11, 17 and 21.
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir MC
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky MC
city: Tsefat
country: Israel
facility: Ziv MC
Study officials:
References: