COVID-19Phase 1NCT05348772
A First-In-Human Phase 1b Study of AmnioPul-02 in COVID-19 / Other LRTI
A Phase 1 study testing AmnioPul-02 in people with COVID-19, run by Amniotics AB at 1 site in Sweden.
Trial summary
This is a first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3, with from 3 up to 6 cohorts i.e. 9-18 subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- AmnioPul-02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 10 Oct 2022to 9 Feb 2023
- Phase
- Phase 1
- 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
- Subjects ≥18 to ≤80 years of age with a diagnosis of moderate or severe COVID-19, with or without pneumonia, as follows:
- SARS-CoV-2 infection, as confirmed by RT-PCR test within 72 hours before dosing.
- Subjects hospitalised primarily due to COVID-19, with symptoms considered typical for COVID-19 (eg, fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath, or dyspnoea requiring oxygen treatment).
- A score of 4, 5, or 6 on the NIAID 8-point ordinal scale for COVID-19 severity, as follows (Beigel et al 2020, Appendix II):
- Score 4: Hospitalised, not requiring supplemental oxygen, but requiring ongoing medical care (related to COVID-19 or to other medical conditions). ii. Score 5: Hospitalised, requiring any supplemental oxygen. iii. Score 6: Hospitalised, requiring non-invasive ventilation or use of high-flow oxygen devices.
- Willing and able to give written informed consent prior to the initiation of any trial procedure.
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- For females only: At the time of enrolment, negative beta human chorionic gonadotropin (β-hCG) pregnancy test (serum) for women of childbearing potential (WOCBP). A woman will be considered WOCBP following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- If the subject is a WOCBP, must agree to practice highly effective method of contraception from screening visit and until 30 days after the last investigational medicinal product (IMP) administration. Highly effective methods of contraception include: a. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: i. Oral ii. Intravaginal iii. Transdermal b. Progestogen-only hormonal contraception associated with inhibition of ovulation: i. Oral ii. Injectable iii. Implantable c. Intrauterine devices d. Intrauterine hormone-releasing system e. Bilateral tubal occlusion f. Vasectomized partner g. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the subject) Note: Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective contraceptive methods.
Who cannot join
- Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment in this trial (subjects who are in a follow-up period of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent).
- Life expectancy <72 hours, in the opinion of the Investigator.
- Subjects requiring invasive mechanical ventilation or ECMO.
- Subjects on non-invasive CPAP ventilation or HFNO (score 6 of the NIAID 8-point ordinal scale for COVID-19 severity; Beigel et al 2020, Appendix II) are allowed, but will be excluded if they have moderate to severe ARDS (eg, same day ratio of arterial partial pressure of oxygen to fraction of inspired oxygen [PaO2/FiO2] ≤200 mmHg; or oxygen saturation [SpO2]/FiO2 ≤232 if arterial blood gas test is not available).
- Active known cancer disease, except subjects with nonaggressive cancers such as basal cell carcinoma, or cervical carcinoma in situ.
- Clinical evidence of active infection, in addition to the SARS-CoV-2 infection, including influenza.
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- Body weight >120 kg.
- Pregnant or breastfeeding female subject.
- Alzheimer's disease or dementia or any other medical condition that, in the opinion of the investigator, impact the subject's capability to properly consent with trial participation or to comply with trial protocol procedures.
- Signs of disseminated intravascular coagulation as per the investigator's medical judgement based on the symptoms of the subject, such as unexplained bleeding, along with subject's laboratory parameters including platelet count, prothrombin time-international normalised ratio (PT-INR), partial thromboplastin time (PTT), plasma fibrinogen, and plasma D-dimer.
- Creatinine clearance <30 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations.
- Abnormal liver chemistry, defined as ALT or aspartate aminotransferase (AST) or total bilirubin or PT-INR >1.5 × upper limit of normal (ULN).
- Severe cardiovascular diseases (severe or unstable angina, congestive heart failure (New York Heart Association [NYHA] III-IV), myocardial infarction within past 1 year, uncontrolled hypertension, and uncontrolled arrhythmia).
- Electrocardiogram (ECG) findings with corrected QT interval using Fridericia's (QTcF) formula >500 msec.
- Subjects with a known or suspected hypersensitivity to MSCs or contaminants (DMSO and Accutase).
- COVID-19 vaccine administered within less than 14 days prior to screening.
- Known thrombosis or thromboembolic event (TEE) or known medical history of TEEs (eg, cerebrovascular accidents, transient ischemic attack, myocardial infarction, pulmonary embolism, and deep vein thrombosis) within the previous 3 months or those subjects particularly at risk for TEEs (eg, history of thrombophilia, permanent immobilisation, or permanent paralysis of their lower extremities).
- Any other medical condition which, in the opinion of the investigator, would impact the safety of the subject or interfere with the subject's ability to comply with the trial and follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-In-Human Phase 1b, Open-Label Trial to Evaluate Safety and Tolerability of a Novel Somatic Cell Therapy, AmnioPul-02,in Subjects With Confirmed COVID-19 or Other Viral Lower Respiratory Tract Infections
This is a first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3, with from 3 up to 6 cohorts i.e. 9-18 subjects.
Read the detailed description
This is a first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3. After a minimum safety follow-up of 7 days of the last subject in each of the cohorts where a higher dosing level may be introduced, a decision on whether to escalate, de-escalate, or stay at the current dose will be taken considering safety and efficacy data from all subjects who have been treated at the current dose level. The trial design is an adapted version of the i3+3 design and will apply 3 dose levels to separate cohorts of 3 subjects. The trial will be restricted with respect to a maximum of 9 subjects to be exposed within a dose level, and a maximum of 18 subjects to be enrolled in the trial.
- Conditions
- COVID-19
- Being tested
- AmnioPul-02
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmnioPul-02Drug
Mesenchymal stem / stromal cells, MSC
| Study group | Role | What they receive |
|---|---|---|
| AmnioPul-02 Dose level 1 | Active comparator | AmnioPul-02 Dose level 1 Receives: Drug: AmnioPul-02 |
| AmnioPul-02 Dose level 2 | Active comparator | AmnioPul-02 Dose level 2 Receives: Drug: AmnioPul-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting adverse events/toxicities (DLTs)
The primary endpoint is the number of subject dose-limiting adverse events/toxicities (DLTs) associated with administration of AmnioPul-02 at each dose level.
Measured: Day 7
Secondary outcomes (6)
OS
Overall survival defined as time from ATIMP infusion to death for any cause
Measured: Day 22
Event-free survival
Event-free survival (defined as time from ATIMP infusion to "event" or death)
Measured: Day 22
Ventilator-free days
Ventilator-free days defined as days alive and free from mechanical ventilation
Measured: Day 22
Time to clinical response
Time to clinical response defined as time from ATIMP infusion to improvement of at least 1 point in the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale for COVID-19 severity
Measured: Day 22
OS
Overall survival defined as time from ATIMP infusion to death for any cause
Measured: 1 year
Time to hospital discharge
Time to hospital discharge defined as time from ATIMP infusion to time to hospital discharge
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start10 Oct 2022
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential Cohorts
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amniotics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348772
- Sponsor's protocol ID
- AmnioPul-02-001
- Status last verified
- Mar 2023
- First submitted
- 26 Apr 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human Phase 1b, Open-Label Trial to Evaluate Safety and Tolerability of a Novel Somatic Cell Therapy, AmnioPul-02,in Subjects With Confirmed COVID-19 or Other Viral Lower Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT05348772
- Acronym / sponsor ID
- AmnioPul-02-001
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Amniotics ABIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 27 Apr 2022 (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 first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3, with from 3 up to 6 cohorts i.e. 9-18 subjects.
Detailed description
This is a first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3. After a minimum safety follow-up of 7 days of the last subject in each of the cohorts where a higher dosing level may be introduced, a decision on whether to escalate, de-escalate, or stay at the current dose will be taken considering safety and efficacy data from all subjects who have been treated at the current dose level. The trial design is an adapted version of the i3+3 design and will apply 3 dose levels to separate cohorts of 3 subjects. The trial will be restricted with respect to a maximum of 9 subjects to be exposed within a dose level, and a maximum of 18 subjects to be enrolled in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Cohorts
| Arm | Type | Receives |
|---|---|---|
| AmnioPul-02 Dose level 1 | Active comparator | Drug: AmnioPul-02AmnioPul-02 Dose level 1 |
| AmnioPul-02 Dose level 2 | Active comparator | Drug: AmnioPul-02AmnioPul-02 Dose level 2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects ≥18 to ≤80 years of age with a diagnosis of moderate or severe COVID-19, with or without pneumonia, as follows:
- Willing and able to give written informed consent prior to the initiation of any trial procedure.
- For females only: At the time of enrolment, negative beta human chorionic gonadotropin (β-hCG) pregnancy test (serum) for women of childbearing potential (WOCBP). A woman will be considered WOCBP following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- If the subject is a WOCBP, must agree to practice highly effective method of contraception from screening visit and until 30 days after the last investigational medicinal product (IMP) administration. Highly effective methods of contraception include: a. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: i. Oral ii. Intravaginal iii. Transdermal b. Progestogen-only hormonal contraception associated with inhibition of ovulation: i. Oral ii. Injectable iii. Implantable c. Intrauterine devices d. Intrauterine hormone-releasing system e. Bilateral tubal occlusion f. Vasectomized partner g. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the subject) Note: Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective contraceptive methods.
Key exclusion criteria (18 listed)
- Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment in this trial (subjects who are in a follow-up period of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent).
- Life expectancy <72 hours, in the opinion of the Investigator.
- Subjects requiring invasive mechanical ventilation or ECMO.
- Subjects on non-invasive CPAP ventilation or HFNO (score 6 of the NIAID 8-point ordinal scale for COVID-19 severity; Beigel et al 2020, Appendix II) are allowed, but will be excluded if they have moderate to severe ARDS (eg, same day ratio of arterial partial pressure of oxygen to fraction of inspired oxygen [PaO2/FiO2] ≤200 mmHg; or oxygen saturation [SpO2]/FiO2 ≤232 if arterial blood gas test is not available).
- Active known cancer disease, except subjects with nonaggressive cancers such as basal cell carcinoma, or cervical carcinoma in situ.
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 |
|---|---|---|
| AmnioPul-02Mesenchymal stem / stromal cells, MSC | Drug | AmnioPul-02 Dose level 1, AmnioPul-02 Dose level 2 |
Primary outcome
Dose-limiting adverse events/toxicities (DLTs)
Time frame: Day 7
The primary endpoint is the number of subject dose-limiting adverse events/toxicities (DLTs) associated with administration of AmnioPul-02 at each dose level.
6 secondary outcomes
OS
Time frame: Day 22
Event-free survival
Time frame: Day 22
Ventilator-free days
Time frame: Day 22
Time to clinical response
Time frame: Day 22
OS
Time frame: 1 year
Time to hospital discharge
Time frame: Day 22
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 10 Mar 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AmnioPul-02 in people with COVID-19, run by Amniotics AB at 1 site in Sweden.
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 9 inclusion and 18 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 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Dose-limiting adverse events/toxicities (DLTs) (time frame: Day 7). 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 10 Mar 2023.