Infections

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Death

Communicable Diseases

Respiratory Insufficiency

COVID-19

Respiratory Tract Infections

Pneumonia

Pneumonia, Viral

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Respiration Disorders

Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation

In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)

Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.

Tocilizumab

Boglarka Gyurkocza, MD

The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.

Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection

A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.

Memorial Sloan Kettering Cancer Center

Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation

Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.

Intubation/Mechanical Ventilation

In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)

Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.

Respiratory Support

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Boglarka Gyurkocza, MD

Progression of Respiratory Failure or Death

Overall Study

Neoplasms

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

Anti-Infective Agents

All Drugs and Chemicals

Ribavirin

Antimetabolites

Antiviral Agents

Aerosolized Ribavirin 6 grams over 18 hours every 24 hours

Aerosolized Ribavirin 2 grams over 3 hours every 8 hours

Arm 1 = 6 Grams Over 18 hours Every 24 Hours

Arm 2 = 2 Grams Over 3 Hours Every 8 Hours.

Roy F. Chemaly, MD

Primary Objectives:

1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia.
2. To determine the effect of this regimen on persistence of viral shedding.

Ribavirin is the drug that is normally given to treat upper respiratory infections caused by RSV. The drug is only effective when inhaled as an aerosol. This treatment requires the patient to be in a tent and inhale the medication. The usual method for administering this drug has been to inhale the medication continuously over 18 hours. In this study, the same total dose of the medication will be used, however, treatment will be for 3 hours every 8 hours.

As part of your standard care, before treatment you will have blood drawn (around 2 teaspoons) for routine blood tests. You will have a washing from your throat and nose collected. For this procedure, around 1 teaspoon of saline will be sprayed into each nostril and you will blow your nose into a cup. You will have a swab of the nose and throat. You will also have a chest x-ray to check on the status of the disease. Women who are able to have children must have a negative blood or urine pregnancy test.

Before treatment, you will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in one group will receive treatment with ribavirin over 3 hours every 8 hours. Participants in the other group will receive treatment using the standard treatment schedule, ribavirin over 18 hours every 24 hours.

For both groups, the drug will be administered as an aerosol using a face mask. This will require you to be in a tent while you are receiving therapy. Treatment will last between 5 and 10 days. This will require hospitalization. In addition to ribavirin treatment, you will also receive Xopenex inhalation therapy every 6 - 8 hours. Xopenex is a drug designed to make breathing easier. We may need to use another breathing treatment, albuterol inhalation therapy for one time if needed, directly after receiving ribavirin to make breathing easier.

Every 2-4 days during treatment you will have blood collected (around 2 teaspoons) for routine tests. On Days 3 and 7 of treatment (+/- 2 days), you will have a repeat throat and nose washings/swabs. The washings and swabs will then be repeated once a week for 2 weeks, or until 2 consecutive cultures are negative, if that occurs sooner. If your doctor feels it is necessary, you may have a repeat chest x-ray.

If at any time you develop signs of pneumonia, you will be removed from the study and will be treated with the standard schedule of ribavirin by continuous inhalation and/or other therapy for 18 hours a day. Also, if you develop any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

This is an investigational study. Ribavirin is FDA approved and is commercially available. However, the method of administration of ribavirin is investigational. Up to 50 patients will participate in this study. All will be enrolled at M. D. Anderson.

Intermittent Use of Aerosolized Ribavirin for Treatment of RSV

A Randomized Study Evaluating Two Different Schedules of Aerosolized Ribavirin For Treatment of RSV Upper Respiratory Infections in Patients With Hematological Malignancies

Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint.

ICN Pharmaceuticals

M.D. Anderson Cancer Center

Aerosolized Ribavirin 6 gm over 18 hours every 24 hours

Standard Schedule - Ribavarin

Aerosolized Ribavirin 6 gm over 3 hours every 8 hours

Modified Schedule - Ribavarin

Age, Categorical

Age Continuous

The interpretation of our data is limited by our study's open-label design, which may bias assessments of tolerability or toxicity but would be less likely to bias assessments of therapeutic endpoints.

Roy F Chemaly, MD/MPH, MBA /Associate Professor

The analysis was carried out per protocol. All patients enrolled were included in the final analysis except one patient who was a screen failure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection	NCT04377659	COVID-19	Tocilizumab	18 Years -	Memorial Sloan Kettering Cancer Center
Intermittent Use of Aerosolized Ribavirin for Treatment of RSV	NCT00500578	Hematological M...	Ribavirin Ribavirin	5 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for respiratory infection