Therapeutic development of adrenomedullin for severe pneumonia caused by COVID-19

JRCT ID: jRCT2071200041

Registered date:12/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 25/11/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Intravenous infusion of investigative drug (adrenomedullin or placebo) will be started immediately after the introduction of mechanical ventilation. The administration of the drug are maintained 72 hour and then intermittent administration (8 hours per day) are followed up to 10 days. The drug administration will be stop after withdrawal of mechanical ventilation.

Outcome(s)

• Primary Outcome: Period of mechanical ventilation (days)

Secondary Outcome

the distribution of clinical status assessed on the 6-point ordinal scale on study day 15 and 30
The changes of cytokines
Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both
• Include criteria: patients with mechanical ventilation required pneumonia caused by COVID-19

Exclude criteria

patients with liver dysfunction (AST and/or ALT > 5 times of reference values)
patients with renal dysfunction (serum creatinine > 2.0 mg/dl)
patients with severe ECG abnormalities and/or cardiac diseases
patients with malignancy or history of malignancy
patients who are expected to transfer to other hospital within 72 hours
pregnant or lactating women

Related Information

• Primary Sponsor: Kita Toshihiro