CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

WFI 5% glucoseWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug73 AMY-101 Wiki 1.00
drug262 Azithromycin Wiki 0.17
drug1086 Hydroxychloroquine Wiki 0.10

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D013577 Syndrome NIH 0.11
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.10
D012128 Respiratory Distress Syndrome, Adult NIH 0.09

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 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.

NCT04395456 Acute Respiratory Distress Syndrome Due to SARS-CoV-2 Infection (Severe COVID19) Drug: AMY-101 Other: WFI 5% glucose
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

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: 21 days

Description: 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.

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

Time: 21 days

Secondary Outcomes

Description: 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.

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

Time: On days 7, 14, and 44

Measure: Proportion of patients surviving

Time: Through to day 44

Description: With respiratory failure defined as any of the following: 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), Persistent respiratory distress while receiving oxygen (persistent marked dyspnea,use of accessory respiratory muscles, paradoxical respiratory movements), Transfer to the intensive care unit for intubation, Death.

Measure: Proportion of respiratory failure-free survival

Time: Day 44

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

Time: Through day 44

Measure: Cumulative incidence of freedom from oxygen requirement

Time: Through day 44

Measure: Proportion of patients requiring invasive mechanical ventilation due to worsening of ARDS

Time: Within 14 days after inclusion in the study

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

Time: Within 14 days after inclusion in the study

Measure: Proportion of patients developing thrombotic microangiopathies

Time: Through day 44

Measure: Changes in PaO2 and PaO2/FIO2

Time: Through day 44

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

Time: Through day 44

Measure: Changes in maximal and minimal cardiovascular parameters: Respiratory rate

Time: Through day 44

Measure: Changes in maximal and minimal cardiovascular parameters: Heart Rate

Time: Through day 44

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

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

Measure: Length of stay in ICU

Time: Through day 44

Measure: Cumulative incidence of discharge from hospital

Time: Through day 44

Measure: Number of adverse events

Time: Through day 44

Measure: Changes in levels of anti-drug antibodies

Time: On day 0 , 14 and 44

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

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

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

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

Measure: Changes in levels of Club Cell protein CC16 (biomarker of lung damage )

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

Measure: Changes in levels of AMY-101 plasma level

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

No related HPO nodes (Using clinical trials)