Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm
NCT ID: NCT04355247
Last Updated: 2020-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2020-04-14
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
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.
PREVENTION
NONE
Study Groups
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Single Arm
* 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.
MethylPREDNISolone 80 Mg/mL Injectable Suspension
* 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.
Interventions
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MethylPREDNISolone 80 Mg/mL Injectable Suspension
* 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Auxilio Mutuo Cancer Center
OTHER
Responsible Party
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Fernando Cabanillas
Medicine Doctor/Medical Director
Principal Investigators
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Fernando Cabanillas, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Español Auxilio Mutuo
Locations
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Hospital Auxilio Mutuo Cancer Center
San Juan, PR, Puerto Rico
San Juan City Hospital / Puerto Rico Medical Center
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Carmelo Santana-López, MD
Role: primary
References
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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. RETRACTED: 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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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The potential role of IL-6 in monitoring severe case of coronavirus disease 2019
Level of IL-6 predicts respiratory failure in hospitalized symptomatic COVID-19 patients
Other Identifiers
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CCAM 20-01
Identifier Type: -
Identifier Source: org_study_id
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