Back to results

Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

Primary Purpose

Covid-19

Status

Unknown status

Phase

Phase 2

Locations

Puerto Rico

Study Type

Interventional

Intervention

MethylPREDNISolone 80 Mg/mL Injectable Suspension

About this trial

This is an interventional prevention trial for Covid-19 focused on measuring Severe Acute Respiratory Syndrome (SARS)-Cov-2 Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients diagnosed with Covid-19 will be registered on the study regardless pf their severity, but only those who meet high risk criteria will be treated with steroids. Those who don't meet the criteria will only be registered with no need to collect further data except baseline labs and CT Chest. They should sign the consent form and the data manager can collect the rest of the information.
Patients older than 18 years diagnosed with Covid-19 by Polymerase Chain Reaction (PCR) or by rapid serological test will be eligible. Cases who are Immunoglobulin G (IgG) positive but Immunoglobulin M (IgM) negative, will not be considered eligible unless they are positive for molecular PCR test. Eligible patients will be registered on study on or before 7 days from first onset of symptoms.

Exclusion Criteria:

Any patient with life expectancy < 1 month
Any patient who is oxygen dependent
Any patient with long standing history of severe Chronic Obstructive Pulmonary Disease (COPD)
Any patient who is chronically oxygen dependent because of previous existing lung disease
Anyone with severely uncontrolled diabetes despite adequate management
Anyone with active serious bacterial infection such as septicemia or pneumonia
Anyone receiving Tocilizumab (anti IL-6 therapy) or plasma therapy
Any patient already receiving steroids from another pre-existing illness

Sites / Locations

San Juan City Hospital / Puerto Rico Medical CenterRecruiting
Hospital Auxilio Mutuo Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Patients will be admitted to a regular room in the hospital (not ICU) They will be monitored closely with vital signs every 4 hours to ensure their respiratory and cardiovascular status do not deteriorate. Methylprednisolone 80 mg IV bolus injection will be given daily x 5 days starting upon day 1 of admission to hospital.

Outcomes

Primary Outcome Measures

Clinical complete response criteria

Clinical complete response criteria requires all the following: No need for ventilatory support at any point O2 Saturation of >/= 93% by day 14 of therapy Alive by day 28 from registration CT chest with minimal or no evidence of disease by day 28 from registration

Clinical Partial Response criteria

Clinical Partial Response criteria require that 2 of the following be present by day 14 of therapy: No need for ventilatory support at any point O2 saturation > 93% bay day 14 from registration CT chest stable to improve over baseline by day 28 from registration

Secondary Outcome Measures

Secondary response criteria

Decrease of at least 25% in anyone of the following markers: IL-6, Ferritin, D-dimer, C reactive protein (CRP) or LDH by day 14 - Improvement of absolute lymphocyte count in those presenting with lymphopenia. Improvement is defined as increase by 25% or more by day 14.

Full Information

NCT ID

NCT04355247

First Posted

April 17, 2020

Last Updated

April 17, 2020

Sponsor

Auxilio Mutuo Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04355247

Brief Title

Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

Official Title

Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 14, 2020 (Actual)

Primary Completion Date

July 31, 2020 (Anticipated)

Study Completion Date

April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Auxilio Mutuo Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a Phase II pilot exploratory study designed to investigate if prophylactic treatment with short term steroids administered to high risk Covid-19 patient might prevent cytokine storm and progression to respiratory failure. High risk is defined based on serologic markers of inflammation that include abnormalities of Interleukin 6 (IL-6), Ferritin , D-dimer, Lactate Dehydrogenase (LDH), as well as lymphopenia and impaired O2 saturation prior to or on the 7th day of first symptom of Covid-19.

Detailed Description

To decrease the rate of progression to hypoxemic respiratory failure in high risk patients with Covid-19, treated with prophylactic steroids during the first phase of the disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid-19

Keywords

Severe Acute Respiratory Syndrome (SARS)-Cov-2 Virus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

This is a pilot Phase II exploratory study. It is a non-randomized study which will be carried out at Auxilio Mutuo Hospital and possibly at other institutions to be recruited. The investigator plans to enter a total of 20 patients in order to determine whether the risk of progressing to respiratory failure can be reduced by administering corticosteroids. The investigator assume that virtually all patients who met the criteria for entry into this trial will develop respiratory insufficiency if left untreated. If </= 50% of patients with high risk develop respiratory failure the investigator will consider the treatment as successful.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

MethylPREDNISolone 80 Mg/mL Injectable Suspension

Intervention Description

Primary Outcome Measure Information:

Title

Clinical complete response criteria

Description

Time Frame

14 days

Title

Clinical Partial Response criteria

Description

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Secondary response criteria

Description

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients diagnosed with Covid-19 will be registered on the study regardless pf their severity, but only those who meet high risk criteria will be treated with steroids. Those who don't meet the criteria will only be registered with no need to collect further data except baseline labs and CT Chest. They should sign the consent form and the data manager can collect the rest of the information. Patients older than 18 years diagnosed with Covid-19 by Polymerase Chain Reaction (PCR) or by rapid serological test will be eligible. Cases who are Immunoglobulin G (IgG) positive but Immunoglobulin M (IgM) negative, will not be considered eligible unless they are positive for molecular PCR test. Eligible patients will be registered on study on or before 7 days from first onset of symptoms. Exclusion Criteria: Any patient with life expectancy < 1 month Any patient who is oxygen dependent Any patient with long standing history of severe Chronic Obstructive Pulmonary Disease (COPD) Any patient who is chronically oxygen dependent because of previous existing lung disease Anyone with severely uncontrolled diabetes despite adequate management Anyone with active serious bacterial infection such as septicemia or pneumonia Anyone receiving Tocilizumab (anti IL-6 therapy) or plasma therapy Any patient already receiving steroids from another pre-existing illness

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fernando Cabanillas, MD

Phone

787-758-2000

Ext

3503

cabanillasmd@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Idalia Liboy, MD

Phone

787-758-2000

Ext

3569

iliboy@auxiliomutuo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando Cabanillas, MD

Organizational Affiliation

Hospital Español Auxilio Mutuo

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Juan City Hospital / Puerto Rico Medical Center

City

San Juan

ZIP/Postal Code

00917

Country

Puerto Rico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carmelo Santana-López, MD

Phone

787-480-2700

Facility Name

Hospital Auxilio Mutuo Cancer Center

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernando Cabanillas, MD

Phone

787-758-2000

Ext

3513

cabanillasmd@gmail.com

First Name & Middle Initial & Last Name & Degree

Idalia Liboy, MD

Phone

787-758-2000

Ext

3569

iliboy@auxiliomutuo.com

First Name & Middle Initial & Last Name & Degree

Fernando Cabanillas, MD

First Name & Middle Initial & Last Name & Degree

Carmelo Santana-López, MD

First Name & Middle Initial & Last Name & Degree

James Bryan, MD

First Name & Middle Initial & Last Name & Degree

Juan Arraut, MD

First Name & Middle Initial & Last Name & Degree

José Abreu-Arbelo, MD

First Name & Middle Initial & Last Name & Degree

Luis Cotto, MD

First Name & Middle Initial & Last Name & Degree

Mirelis Acosta-Rivera, MD

First Name & Middle Initial & Last Name & Degree

Margarita Bruno, MD

First Name & Middle Initial & Last Name & Degree

Idalia Liboy, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

32205204

Citation

Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.

Results Reference

background

PubMed Identifier

32113510

Citation

Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.

Results Reference

background

PubMed Identifier

32264963

Citation

Carr AC. A new clinical trial to test high-dose vitamin C in patients with COVID-19. Crit Care. 2020 Apr 7;24(1):133. doi: 10.1186/s13054-020-02851-4. No abstract available.

Results Reference

background

PubMed Identifier

32171076

Citation

Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

Results Reference

background

PubMed Identifier

32234467

Citation

Zhang C, Wu Z, Li JW, Zhao H, Wang GQ. Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality. Int J Antimicrob Agents. 2020 May;55(5):105954. doi: 10.1016/j.ijantimicag.2020.105954. Epub 2020 Mar 29.

Results Reference

background

PubMed Identifier

32167524

Citation

Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.

Results Reference

background

PubMed Identifier

32043983

Citation

Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020 Feb 15;395(10223):473-475. doi: 10.1016/S0140-6736(20)30317-2. Epub 2020 Feb 7. No abstract available.

Results Reference

background

PubMed Identifier

32275812

Citation

Grein J, Ohmagari N, Shin D, Diaz G, Asperges E, Castagna A, Feldt T, Green G, Green ML, Lescure FX, Nicastri E, Oda R, Yo K, Quiros-Roldan E, Studemeister A, Redinski J, Ahmed S, Bernett J, Chelliah D, Chen D, Chihara S, Cohen SH, Cunningham J, D'Arminio Monforte A, Ismail S, Kato H, Lapadula G, L'Her E, Maeno T, Majumder S, Massari M, Mora-Rillo M, Mutoh Y, Nguyen D, Verweij E, Zoufaly A, Osinusi AO, DeZure A, Zhao Y, Zhong L, Chokkalingam A, Elboudwarej E, Telep L, Timbs L, Henne I, Sellers S, Cao H, Tan SK, Winterbourne L, Desai P, Mera R, Gaggar A, Myers RP, Brainard DM, Childs R, Flanigan T. Compassionate Use of Remdesivir for Patients with Severe Covid-19. N Engl J Med. 2020 Jun 11;382(24):2327-2336. doi: 10.1056/NEJMoa2007016. Epub 2020 Apr 10.

Results Reference

background

Links:

URL

https://www.medrxiv.org/content/10.1101/2020.03.01.20029769v2

Description

The potential role of IL-6 in monitoring severe case of coronavirus disease 2019

URL

https://www.medrxiv.org/content/10.1101/2020.04.01.20047381v2

Description

Level of IL-6 predicts respiratory failure in hospitalized symptomatic COVID-19 patients

Learn more about this trial

Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

We'll reach out to this number within 24 hrs