Covid-19Phase 2NCT04355247
Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm
A Phase 2 study testing MethylPREDNISolone 80 Mg/mL Injectable Suspension in people with Covid-19, run by Auxilio Mutuo Cancer Center at 2 sites in Puerto Rico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- MethylPREDNISolone 80 Mg/mL Injectable Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesPuerto Rico
- Study dates
- 14 Apr 2020to 30 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Puerto Rico2 sites, 2 recruiting
- Recruiting
Hospital Auxilio Mutuo Cancer Center
San Juan, PR, 00918
Fernando Cabanillas, MD, 787-758-2000 ext. 3513, cabanillasmd@gmail.com
Idalia Liboy, MD, 787-758-2000 ext. 3569, iliboy@auxiliomutuo.com
- Recruiting
San Juan City Hospital / Puerto Rico Medical Center
San Juan, 00917
Carmelo Santana-López, MD, 787-480-2700
About this study
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.
Read the 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.
- Conditions
- Covid-19
- Being tested
- MethylPREDNISolone 80 Mg/mL Injectable Suspension
- Keywords
- Severe Acute Respiratory Syndrome (SARS)-Cov-2 Virus
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylPREDNISolone 80 Mg/mL Injectable SuspensionDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | * 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. Receives: Drug: MethylPREDNISolone 80 Mg/mL Injectable Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
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
Measured: 14 days
Secondary outcomes (1)
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start14 Apr 2020
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auxilio Mutuo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Cabanillas, Auxilio Mutuo Cancer Center
- Investigators
- Fernando Cabanillas, MD, Principal investigator, Hospital Español Auxilio Mutuo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355247
- Sponsor's protocol ID
- CCAM 20-01
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32205204Chen 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.
PubMed 32113510Carr 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.
PubMed 32264963Zhou 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.
PubMed 32171076Zhang 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.
PubMed 32234467Wu 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.
PubMed 32167524Russell 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.
PubMed 32043983Grein 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.
PubMed 32275812
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm
- ClinicalTrials.gov ID
- NCT04355247
- Acronym / sponsor ID
- CCAM 20-01
- Conditions
- Covid-19
- Keywords
- Severe Acute Respiratory Syndrome (SARS)-Cov-2 Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Auxilio Mutuo Cancer CenterUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Single Arm |
Primary outcome
Clinical complete response criteria
Time frame: 14 days
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
Time frame: 14 days
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
1 secondary outcome
Secondary response criteria
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Background: PubMed 32205204Gautret 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.
- Background: PubMed 32113510Chen 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.
- Background: PubMed 32264963Carr 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.
- Background: PubMed 32171076Zhou 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.
- Background: PubMed 32234467Zhang 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.
- Background: PubMed 32167524Wu 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.
- Background: PubMed 32043983Russell 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.
- Background: PubMed 32275812Grein 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.
- Level of IL-6 predicts respiratory failure in hospitalized symptomatic COVID-19 patientsLink provided by the sponsor.
Related trials for Covid-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Cabanillas, MD principal investigator
Hospital Español Auxilio Mutuo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MethylPREDNISolone 80 Mg/mL Injectable Suspension in people with Covid-19, run by Auxilio Mutuo Cancer Center at 2 sites in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Cabanillas, MD (787-758-2000 ext. 3503, cabanillasmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical complete response criteria (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04355247, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.