Covid19Phase 1/2NCT04900337
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 study testing AMOR 18 Powder & Inhalation in people with Covid19, run by Amorphical Ltd. at 3 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- AMOR 18 Powder & Inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 3 sitesIsrael
- Study dates
- 9 Feb 2021to 30 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Hyperphosphatemia defined as > 4.5mg/dL
- Urine calcium to creatinine ratio >0.14
- Participating in another clinical study
Trial locations and contacts
3 sites in 1 country.
About this study
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.
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).
Read the 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:
- Confirmation SARS-CoV-2 infection
- Respiratory Function (breathing rate, SpO2 Oxygen Saturation
- Vital Signs (BP, HR), Temperature
- Blood Tests
- 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
- Being tested
- AMOR 18 Powder & Inhalation, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMOR 18 Powder & InhalationDrug
AMOR Inhalation x 3 times a day, via Circulaire® II AMOR Powder x 4 times a day, sublingual
PlaceboDrug
Placebo Inhalation x 3 times a day, via Circulaire® II Placebo Powder x 4 times a day, sublingual
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Treatment Day 1 to Day 21 or discharge from hospital, the earliest.
Secondary outcomes (9)
Duration of Hospital stay
Time to discharge from hospital
Measured: Date of hospitalization to treatment day 21 or discharge, whichever comes first.
Duration of ICU stay
Time patient is hospitalized in ICU, if applicable.
Measured: 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)
Measured: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Duration of Oxygen Supplementation
Time the patient requires Oxygen Supplementation (if needed)
Measured: 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
Measured: 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).
Measured: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
% of death
Proportion of subjects died during the study, if any.
Measured: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Frequency and severity of adverse events
Measured: Screening to End of treatment day 21 or discharge, whichever comes first.
Number and percent of patients with hypercalcemia
Measured: Treatment days 4, 7, 11, 17 and 21.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start9 Feb 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorphical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900337
- Sponsor's protocol ID
- AMCS-COVID-001
- Status last verified
- Feb 2024
- First submitted
- 19 May 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04900337
- Acronym / sponsor ID
- AMCS-COVID-001
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Amorphical Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Confirmation SARS-CoV-2 infection
- Respiratory Function (breathing rate, SpO2 Oxygen Saturation
- Vital Signs (BP, HR), Temperature
- Blood Tests
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMOR 18 Powder & Inhalation | Experimental | Drug: AMOR 18 Powder & InhalationAMOR_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). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo_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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMOR 18 Powder & InhalationAMOR Inhalation x 3 times a day, via Circulaire® II AMOR Powder x 4 times a day, sublingual | Drug | AMOR 18 Powder & Inhalation |
| PlaceboPlacebo Inhalation x 3 times a day, via Circulaire® II Placebo Powder x 4 times a day, sublingual | Drug | Placebo |
Primary outcome
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.
Time frame: Treatment Day 1 to Day 21 or discharge from hospital, the earliest.
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.
9 secondary outcomes
Duration of Hospital stay
Time frame: Date of hospitalization to treatment day 21 or discharge, whichever comes first.
Duration of ICU stay
Time frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Duration of Mechanical Ventilation Use
Time frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Duration of Oxygen Supplementation
Time frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Duration of No Oxygen use
Time frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
% of patients to meet ordinal scale of 3 or less
Time frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
% of death
Time frame: Treatment Day 1 to treatment day 21 or discharge, whichever comes first.
Frequency and severity of adverse events
Time frame: Screening to End of treatment day 21 or discharge, whichever comes first.
Number and percent of patients with hypercalcemia
Time frame: Treatment days 4, 7, 11, 17 and 21.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AMOR 18 Powder & Inhalation in people with Covid19, run by Amorphical Ltd. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Treatment Day 1 to Day 21 or discharge from hospital, the earliest.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.