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Mesencure trial I believe was open label phase wit

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Post# of 154180
(Total Views: 481)
Posted On: 11/30/2021 10:42:09 AM
Posted By: CTMedic
Re: Buddyboy20 #111308
Mesencure trial I believe was open label phase with a control group of ostensibly comparable patients.

Many trials play fast and loose with “severe” clinical status.

Here are the inclusion and exclusion criteria from their trials.

Quote:
Inclusion Criteria:
Patients are able and agree to sign informed consent form before any study-specific procedure.

Males or females, age range 18-80.

Female subjects are eligible only if of non-child bearing potential.

Documented COVID19

O2 Saturation of ≤93%

Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)

Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.

Exclusion Criteria:

General:
Pregnant or breast-feeding females.

History of drug abuse.

Heavy smokers (above 2 packages a day).

Subjects incapable of giving consent.

Background medical conditions:

Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.

History of significant heart diseases, renal failure (estimated GFR of <30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C).

Known autoimmune diseases.

Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an exclusion criteria).
Immunocompromised condition from any reason, at screening.

Abnormal clinically significant laboratory test findings, as per the investigator's judgment.

Poorly controlled diabetic subjects (HbA1c > 9%).

Known active lung malignancy.

Concomitant treatment:

Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID19.

Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.



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