AzTrials
AzTrials

Acute Respiratory Distress Syndrome Due to SARS-CoV-2 Infection (Severe COVID19)Phase 2SAVENCT04395456

A Study of the C3 Inhibitor AMY-101 in Patients With ARDS Due to COVID-19 (SAVE)

A Phase 2 study testing AMY-101 and WFI 5% glucose in people with Acute Respiratory Distress Syndrome Due to SARS-CoV-2 Infection (Severe COVID19), run by Amyndas Pharmaceuticals S.A..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of AMY-101, a potent C3 inhibitor, for the management of patients with ARDS caused by SARS-CoV-2 infection. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AMY-101 and WFI 5% glucose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
No sites listed yet
Study dates
Sep 2021to Dec 2022
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with Acute Respiratory Distress Syndrome due to SARS-CoV-2 infection (severe Covid-19), according to the following criteria:
  • Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swap or bronchio-alveolar lavage (BAL)
  • A ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2), PaO2/FIO2, ≤300 mmHg
  • Mild ARDS (PaO2/FIO2, ≤300 and >200 mm Hg);
  • Moderate ARDS (PaO2/FIO2, ≤200 and >100 mm Hg);
  • Severe ARDS (PaO2/FIO2, ≤100 mm Hg);
  • Pulmonary infiltrates suggestive of SARS-COV-2-related ARDS: e.g., bilateral infiltrates at chest X-ray or B-lines at lung US scan.
  • Dated and signed informed consent from patient or legal represantative.

Who cannot join

  • Intubated patients
  • Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 µg/L)
  • Demonstrated local extrapulmonary abscess
  • ARDS due to cardiac failure or fluid overload
  • Concomitant treatment with immunomodulatory /immunosuppressive drugs , which have potential activity against the disease
  • Multi Organ Failure (MOF)
Show all 14Show fewer
  • Severe renal failure (CKD, by defition glomerular filtration rate <30 ml/min)
  • Neisseria meningitidis infection that is not resolved
  • Current treatment with a complement inhibitor
  • Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening
  • Participation in another interventional treatment study within 30 days before initiation of the study treatment (Day 1 in this study) or within 5 half-lives of that investigational product, whichever is greater.
  • Chemotherapy for less than 3months
  • Pregnancy
  • Age <18.

About this study

Official title: A Phase 2 Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor, AMY-101, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 (SAVE)

The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of AMY-101, a potent C3 inhibitor, for the management of patients with ARDS caused by SARS-CoV-2 infection.

We will assess the efficacy and safety, as well as pharmacokinetics (PK), and pharmacodynamics (PD). The study will assess the impact of AMY-101 in patients with severe COVID19; specifically, it will assess the impact of AMY-101 1) on survival without ARDS and without oxygen requirement at day 21 and 2) on the clinical status of the patients at day 21.

Being tested
AMY-101, WFI 5% glucose
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMY-101Drug

    C3 complement inhibitor

  • WFI 5% glucoseOther

    Placebo

Study groups in NCT04395456
Study groupRoleWhat they receive
AMY-101ExperimentalNot described
Receives: Drug: AMY-101
PlaceboPlacebo comparatorNot described
Receives: Other: WFI 5% glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients who are alive, without evidence of ARDS (i.e. PaO2/FIO2 >300 mm Hg), who do not require any oxygen support (in room air).

    Measured: 21 days

  2. The proportion of patients assigned to each category, of a six-category ordinal scale.

    The clinical status is based on the following six-category ordinal scale:

    • 1: not hospitalised;
    • 2: hospitalised, not requiring supplemental oxygen;
    • 3: hospitalised, requiring supplemental oxygen;
    • 4: hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both;
    • 5: hospitalised, requiring ECMO, invasive mechanical ventilation, or both; and
    • 6: death.

    Measured: 21 days

Secondary outcomes (21)

  1. The proportion of patients assigned to each category, of a six-category ordinal scale.

    The clinical status is based on the following six-category ordinal scale:

    • 1: not hospitalised;
    • 2: hospitalised, not requiring supplemental oxygen;
    • 3: hospitalised, requiring supplemental oxygen;
    • 4: hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both;
    • 5: hospitalised, requiring ECMO, invasive mechanical ventilation, or both; and
    • 6: death.

    Measured: On days 7, 14, and 44

  2. Proportion of patients surviving

    Measured: Through to day 44

  3. Proportion of respiratory failure-free survival

    With respiratory failure defined as any of the following:

    1. Worsening of severe gas transfer deficit, accounting for a shift in ARDS disease category (PaO2/FiO2 ≤200 for patients with PaO2/FiO2 >200 at baseline; PaO2/FiO2 ≤100 for patients with PaO2/FiO2 >100 at baseline),
    2. Persistent respiratory distress while receiving oxygen (persistent marked dyspnea,use of accessory respiratory muscles, paradoxical respiratory movements),
    3. Transfer to the intensive care unit for intubation,
    4. Death.

    Measured: Day 44

  4. Cumulative incidence of resolution of ARDS (defined as PaO2/FiO2 ≥200 in room air)

    Measured: Through day 44

  5. Cumulative incidence of freedom from oxygen requirement

    Measured: Through day 44

  6. Proportion of patients requiring invasive mechanical ventilation due to worsening of ARDS

    Measured: Within 14 days after inclusion in the study

  7. Proportion of patients requiring non-invasive mechanical ventilation (NIV) due to worsening of ARDS

    Measured: Within 14 days after inclusion in the study

  8. Proportion of patients developing thrombotic microangiopathies

    Measured: Through day 44

  9. Changes in PaO2 and PaO2/FIO2

    Measured: Through day 44

  10. Changes in quick Sequential Organ Failure Assessment Score (qSOFA: respiratory rate, systolic blood pressure, Glasgow Coma Scale (GCS)

    Measured: Through day 44

  11. Changes in maximal and minimal cardiovascular parameters: Respiratory rate

    Measured: Through day 44

  12. Changes in maximal and minimal cardiovascular parameters: Heart Rate

    Measured: Through day 44

  13. Changes in levels of biomarkers of inflammation (CBC, CRP, Ferritin, Procalcitonin, D-dimers, LDH)

    Measured: On days 0, 1, 2, 4, 7, 10, 14, 21 and 44

  14. Length of stay in ICU

    Measured: Through day 44

  15. Cumulative incidence of discharge from hospital

    Measured: Through day 44

  16. Number of adverse events

    Measured: Through day 44

  17. Changes in levels of anti-drug antibodies

    Measured: On day 0 , 14 and 44

  18. Changes in levels of biomarkers of complement activity: C3, C3a, C5a, sC5b-9

    Measured: On days 0, 1, 2, 4, 7, 10, 14, 21 and 44

  19. Changes in levels of biomarkers of cytokine release syndrome: IL-1, IL-6, IL-12

    Measured: On days 0, 1, 2, 4, 7, 10, 14, 21 and 44

  20. Changes in levels of Club Cell protein CC16 (biomarker of lung damage )

    Measured: On days 0, 1, 2, 4, 7, 10, 14, 21 and 44

  21. Changes in levels of AMY-101 plasma level

    Measured: On days 1, 2, 4, 7, 10, 14, 15, 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2020
  2. Study startSep 2021 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04395456
Sponsor's protocol ID
AMY-101_SAVE
Acronym
SAVE
Status last verified
Feb 2021
First submitted
19 May 2020
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Risitano AM, Mastellos DC, Huber-Lang M, Yancopoulou D, Garlanda C, Ciceri F, Lambris JD. Complement as a target in COVID-19? Nat Rev Immunol. 2020 Jun;20(6):343-344. doi: 10.1038/s41577-020-0320-7. Epub 2020 Apr 23.

    PubMed 32327719

  • Mastaglio S, Ruggeri A, Risitano AM, Angelillo P, Yancopoulou D, Mastellos DC, Huber-Lang M, Piemontese S, Assanelli A, Garlanda C, Lambris JD, Ciceri F. The first case of COVID-19 treated with the complement C3 inhibitor AMY-101. Clin Immunol. 2020 Jun;215:108450. doi: 10.1016/j.clim.2020.108450. Epub 2020 Apr 29.

    PubMed 32360516

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMY-101 and WFI 5% glucose in people with Acute Respiratory Distress Syndrome Due to SARS-CoV-2 Infection (Severe COVID19), run by Amyndas Pharmaceuticals S.A..

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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

Results are not available in the source record.

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?

The proportion of patients who are alive, without evidence of ARDS (i.e. PaO2/FIO2 >300 mm Hg), who do not require any oxygen support (in room air). (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04395456, which also lists 2 linked publications.

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 21 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in