Cytokine StormPhase 2STORMNCT04433078
RepurpoSing Old Drugs TO SuppRess a Modern Threat: COVID-19 STORM
A Phase 2 study testing Doxycycline in people with Cytokine Storm and SARS-CoV-2, run by Temple University at 1 site in United States.
Trial summary
The primary aim of this study is to test whether Doxycycline can benefit patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections by inhibiting the replication of the virus while at the same time blocking the development of cytokine storms or inhibiting cytokine-associated coagulopathy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytokine Storm, SARS-CoV-2
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2020to 13 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
- Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, not requiring hospitalization
- Age ≥18 years
- Willing to sign the informed consent form
- Willing to take study drug or placebo as directed for 21 days
Who cannot join
- Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, requiring hospitalization
- Suspected or confirmed convalescent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), within the prior 4 weeks
- Age <18 years' old
- Inability to take medications orally
- Inability to provide written consent
- Known sensitivity/allergy to doxycycline or tetracyclines
Show all 13Show fewer
- Current use of doxycycline for another indication
- Pregnancy
- A known diagnosis of myasthenia gravis
- History of Clostridium Difficile infection within past 12 months
- Sun sensitivity
- Individuals using medications which could lower doxycycline levels, including barbiturates, phenytoin, carbamazepine, warfarin
- Individuals using isotretinoin
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: RepurpoSing Old Drugs TO SuppRess a Modern Threat: The STORM Trial
The primary aim of this study is to test whether Doxycycline can benefit patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections by inhibiting the replication of the virus while at the same time blocking the development of cytokine storms or inhibiting cytokine-associated coagulopathy respectively. The investigators hypothesize that Doxycycline will will improve survival and reduce morbidity in SARS-CoV-2 infected patients.
A secondary aim is to identify genetic variants that predict either an unusually mild disease or an unusually severe disease - knowledge that can be used to design new and precise medications and to be able to predict patients who might get into early trouble and to therefore hospitalize them.
Read the detailed description
This study will randomize 20 patients with confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to Doxycycline (100 mg BID) or Placebo and then assess the progression of their disease over the next three weeks with the primary endpoint being days alive and out of the hospital.
The investigators will collect specimens for measurement of viral burden (nasopharyngeal luminex (SARS-CoV-2), SARS-CoV-2 serum quantitative viral load, SARS-CoV-2 IgM/IgG antibodies), markers of inflammation (WBC, ESR, TNFa, IL-1, IL-6, IL-1B), and cardiac dysfunction (CRP, pro-BNP, hsTnT).
Eligibility will be based on history and physical examination findings - collated into a clinical suspicion score. The decision to enroll based on clinical suspicion score rather than confirmed SARS-CoV-2 disease is based on the variable and unacceptably high false negative rate of the nasopharyngeal PCR test for in early disease.
Clinical Suspicion Score: Greater than or equal to 6/20 (at least 4 points of which must be clinical) will be eligible for enrollment.
Clinical Criteria: Max 12 points
- Fever (2 points)
- Cough (2 points)
- Dyspnea (2 points)
- Chest pain (1 point)
- Myalgias (1 point)
- Fatigue (1 point)
- GI symptoms (1 point)
- Loss of Smell (1 point)
- Loss of Taste (1 point)
Exposure Criteria: Max 8 points
- Contact with known COVID+ (2 points)
- Healthcare worker -- frequent <6 feet contact for 15 minutes (2 points)
- High-risk work -- supermarket, deli, transportation (2 points)
- Endemic community -- prison/jail/nursing home/LTAC/SNF/rehab/homeless/homeless shelter (2 points)
Genetic variants may explain why patients who are infected with SARS-CoV-2 have either a relatively benign or an inappropriately aggressive response to an infectious insult. Medications may be more or less effective in that group of patients harboring genetic variants of a disease-related protein. To better understand this, whole genome sequencing and analysis will be performed on all study patients.
- Conditions
- Cytokine Storm, SARS-CoV-2
- Being tested
- Doxycycline, Placebo
- Keywords
- Doxycycline, Cytokine Storm, SARS-CoV-2
- Medical subject headings
- Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
100 MG Tablet
PlaceboDrug
Placebo Tablet
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Experimental | Participants receive 100 MG BID for 21 days Receives: Drug: Doxycycline |
| Placebo | Placebo comparator | Participants receive Placebo BID for 21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death
Days Alive and Out of Hospital (Composite Endpoint)
Measured: 21 days
Secondary outcomes (12)
NP SARS-CoV-2 PCR
Change From Baseline of Nasopharyngeal Luminex NxTAG CoV (Positive/Negative)
Measured: 21 days
SARS-CoV-2 Serum Quantitative Viral Load
Change From Baseline of SARS-CoV-2 Serum Quantitative Viral Load
Measured: 21 days
SARS-CoV-2 IgM/IgG Antibodies
Change From Baseline of SARS-CoV-2 IgM/IgG Antibodies (Positive/Negative)
Measured: 21 days
White Blood Cell Count (WBC)
Change From Baseline of White Blood Count (CBC) K/mm3
Measured: 21 days
Absolute Lymphocyte Count (ALC)
Change From Baseline of Absolute Lymphocyte Count (ALC) K/mm3
Measured: 21 days
C-Reactive Protein (CRP)
Change From Baseline of C-Reactive Protein (CRP) mg/dL
Measured: 21 days
N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP)
Change From Baseline of N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP) pg/mL
Measured: 21 days
High Sensitivity Troponin I (hsTnT)
Change From Baseline of High Sensitivity Troponin I (hsTnT) ng/mL
Measured: 21 days
Tumor Necrosis Factor Alpha (TNF-a)
Change From Baseline of Tumor Necrosis Factor Alpha (TNF-a)
Measured: 21 days
IL-1
Change From Baseline of IL-1
Measured: 21 days
IL-1B
Change From Baseline of IL-1B
Measured: 21 days
IL-6
Change From Baseline of IL-6
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start22 Jun 2020
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Why it stopped: No Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine StormStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will randomize 20 patients with confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) patients to Doxycycline (100 mg BID) or Placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur M Feldman, MD, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433078
- Sponsor's protocol ID
- The STORM Trial
- Acronym
- STORM
- Status last verified
- Apr 2021
- First submitted
- 10 Jun 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RepurpoSing Old Drugs TO SuppRess a Modern Threat: The STORM Trial
- ClinicalTrials.gov ID
- NCT04433078
- Acronym / sponsor ID
- STORM / The STORM Trial
- Conditions
- Cytokine Storm, SARS-CoV-2
- Keywords
- Doxycycline, Cytokine Storm, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 16 Jun 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.
The primary aim of this study is to test whether Doxycycline can benefit patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections by inhibiting the replication of the virus while at the same time blocking the development of cytokine storms or inhibiting cytokine-associated coagulopathy respectively. The investigators hypothesize that Doxycycline will will improve survival and reduce morbidity in SARS-CoV-2 infected patients.
A secondary aim is to identify genetic variants that predict either an unusually mild disease or an unusually severe disease - knowledge that can be used to design new and precise medications and to be able to predict patients who might get into early trouble and to therefore hospitalize them.
Detailed description
This study will randomize 20 patients with confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to Doxycycline (100 mg BID) or Placebo and then assess the progression of their disease over the next three weeks with the primary endpoint being days alive and out of the hospital.
The investigators will collect specimens for measurement of viral burden (nasopharyngeal luminex (SARS-CoV-2), SARS-CoV-2 serum quantitative viral load, SARS-CoV-2 IgM/IgG antibodies), markers of inflammation (WBC, ESR, TNFa, IL-1, IL-6, IL-1B), and cardiac dysfunction (CRP, pro-BNP, hsTnT).
Eligibility will be based on history and physical examination findings - collated into a clinical suspicion score. The decision to enroll based on clinical suspicion score rather than confirmed SARS-CoV-2 disease is based on the variable and unacceptably high false negative rate of the nasopharyngeal PCR test for in early disease.
Clinical Suspicion Score: Greater than or equal to 6/20 (at least 4 points of which must be clinical) will be eligible for enrollment.
Clinical Criteria: Max 12 points
- Fever (2 points)
- Cough (2 points)
- Dyspnea (2 points)
- Chest pain (1 point)
- Myalgias (1 point)
- Fatigue (1 point)
- GI symptoms (1 point)
- Loss of Smell (1 point)
- Loss of Taste (1 point)
Exposure Criteria: Max 8 points
- Contact with known COVID+ (2 points)
- Healthcare worker -- frequent <6 feet contact for 15 minutes (2 points)
- High-risk work -- supermarket, deli, transportation (2 points)
- Endemic community -- prison/jail/nursing home/LTAC/SNF/rehab/homeless/homeless shelter (2 points)
Genetic variants may explain why patients who are infected with SARS-CoV-2 have either a relatively benign or an inappropriately aggressive response to an infectious insult. Medications may be more or less effective in that group of patients harboring genetic variants of a disease-related protein. To better understand this, whole genome sequencing and analysis will be performed on all study patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study will randomize 20 patients with confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) patients to Doxycycline (100 mg BID) or Placebo.
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Experimental | Drug: DoxycyclineParticipants receive 100 MG BID for 21 days |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive Placebo BID for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, not requiring hospitalization
- Age ≥18 years
- Willing to sign the informed consent form
- Willing to take study drug or placebo as directed for 21 days
Key exclusion criteria (13 listed)
- Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, requiring hospitalization
- Suspected or confirmed convalescent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), within the prior 4 weeks
- Age <18 years' old
- Inability to take medications orally
- Inability to provide written consent
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 |
|---|---|---|
| Doxycycline100 MG Tablet | Drug | Doxycycline |
| PlaceboPlacebo Tablet | Drug | Placebo |
Primary outcome
Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death
Time frame: 21 days
Days Alive and Out of Hospital (Composite Endpoint)
12 secondary outcomes
NP SARS-CoV-2 PCR
Time frame: 21 days
SARS-CoV-2 Serum Quantitative Viral Load
Time frame: 21 days
SARS-CoV-2 IgM/IgG Antibodies
Time frame: 21 days
White Blood Cell Count (WBC)
Time frame: 21 days
Absolute Lymphocyte Count (ALC)
Time frame: 21 days
C-Reactive Protein (CRP)
Time frame: 21 days
N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP)
Time frame: 21 days
High Sensitivity Troponin I (hsTnT)
Time frame: 21 days
Tumor Necrosis Factor Alpha (TNF-a)
Time frame: 21 days
IL-1
Time frame: 21 days
IL-1B
Time frame: 21 days
IL-6
Time frame: 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Arthur M Feldman, MD, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline in people with Cytokine Storm and SARS-CoV-2, run by Temple University at 1 site in United States.
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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2021.