MedTrace Logo

The Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With COVID-19

NCT04285190 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-06-16

No results posted yet for this study

Summary

This is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.

Conditions

  • Coronavirus Disease 2019
  • Novel Coronavirus Pneumonia

Interventions

DRUG

T89

The subjects in the T89 treatment group will receive 30 pills of T89 orally, bid., for 10 days, except a standard background treatment (antiviral drug + antibacterial + oxygen therapy+ Traditional Chinese Medicine decoction). The subjects in the blank control group will only receive a standard background treatment.

Sponsors & Collaborators

  • Tasly Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Shuiping Zhou, PhD · Tasly Pharmaceutical Group Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-26
Primary Completion
2020-04-15
Completion
2020-04-20

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285190 on ClinicalTrials.gov