CoVid 19 PositivePhase 2/3FMTVDMNCT04349410
The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol
A Phase 2/3 study testing Hydroxychloroquine, Azithromycin, Hydroxychloroquine, Doxycycline and Hydroxychloroquine, Clindamycin in people with CoVid 19 Positive, run by The Camelot Foundation at 1 site in United States.
Trial summary
Diagnostic determination of disease and treatment responses has been limited to qualitative imaging, measurement of serum markers of disease, and sampling of tissue. In each of these instances, there is a built in error either due to sensitivity and specificity issues, clinician interpretation of results, or… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CoVid 19 Positive
- What is being tested?
- Hydroxychloroquine, Azithromycin, Hydroxychloroquine, Doxycycline and Hydroxychloroquine, Clindamycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2020to 14 Sep 2020
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Diagnostic determination of disease and treatment responses has been limited to qualitative imaging, measurement of serum markers of disease, and sampling of tissue. In each of these instances, there is a built in error either due to sensitivity and specificity issues, clinician interpretation of results, or acceptance of the use of an indirect marker (blood test) of what is happening elsewhere in the body - at the tissue level.
The Fleming Method for Tissue and Vascular Differentiation and Metabolism (FMTVDM) using same state single or sequential quantification comparisons [1] provides the first and only patented test (#9566037) - along with the associated submitted patent applications ruled to be covered under #9566037 - that quantitatively measures changes in tissue resulting from inter alia a disease process. This includes inter alia coronary artery disease (CAD), cancer and infectious/inflammatory processes including CoVid-19 pneumonia (CVP) resulting from the metabolic and regional blood flow differences (RBFDs) caused by these diseases.
The purpose of this paper is to make clinicians and researchers aware of this proposed method for investigating the prevalence and severity of CVP - in addition to providing rapid determination of treatment response in each patient, directing treatment decisions; thereby reducing the loss of time, money, resources and patient lives.
Read the detailed description
FMTVDM - See Appendix A.
- Quantitatively calibrates the nuclear camera to guarantee that the measurements made by the camera are accurate, consistent and reproducible. This quantification is dependent upon the isotope being used, the camera and the timing sequence of image acquisition. Such calibration is NOT currently done and it is part of the patent. Studies have demonstrated that the lack of this quantitative calibration has resulted in up to 1/3 of the data being lost for SUV and qualitative interpretation; in addition to making quantification impossible.
- The patient presents in a fasting state - to eliminate digestive processes from interfering with blood flow distributions - and the differences in metabolic and regional blood flow differences (RBFDs) are enhanced with vasodilatory agents, shifting blood flow and isotope towards regions of greater blood flow and metabolism; enhancing isotope delivery, uptake and quantification.
- With a now quantitatively calibrated nuclear camera - in this instance a PLANAR camera - or SPECT/CT or PET/CT/MRI if specifically approved - to allow imaging to be done at patient's bedside reducing the use of hospital resources required for transport and decrease potential for patient complications resulting from a transport - image acquisition will occur for 10-minutes following peak enhancement effect of the vasodilatory agent and timed injection of the isotope based upon the enhancing agent. Regions-of-interest (ROIs) will drawn by the nuclear technologist - either at the bedside or in the nuclear laboratory - to provide FMTVDM measurements using software already present in the nuclear camera systems. Specific ROIs will be drawn of the right lung (total), left lung (total), mediastinum (thymus activity), and any specific areas where increased tracer uptake is noted.
- These FMTVDM measurements including MAXIMAL COUNTS +/- VARIANCE, provide the values of the most active pulmonary tissue resulting from the CoVid-19 infection and inflammatory response; just as it has previously been used for CAD and Cancer.
- From these FMTVDM measurements, the pulmonary tissue and the CoVid-19 infectious process results are placed on a Health-Spectrum showing where in the tissue transitioning process the patient is. The measurements also provide information about how rapidly the tissue is changing. FMTVDM provides the quantitative measurement of where the patient is at any point in time during their course of treatment and how they compare with other patients.
- Once the FMTVDM measurements have been obtained, treatment decisions can be made based upon serial changes in FMTVDM. Treatments outcomes are based upon FMTVDM measurements, including the maximum FMTVDM and the variance in those measurements. By comparing serial FMTVDM results, improvement or deterioration in the patient's health and the success or failure of the current treatment regimen is measured, providing patient-centered, patient-specific, patient-oriented and patient-directed decisions. Thus saving time, money, resources and lives - not to mention unnecessary side effects from treatment, which is not working.
- Conditions
- CoVid 19 Positive
- Being tested
- Hydroxychloroquine, Azithromycin, Hydroxychloroquine, Doxycycline, Hydroxychloroquine, Clindamycin, Hydroxychloroquine, Clindamycin, Primaquine - low dose., Hydroxychloroquine, Clindamycin, Primaquine - high dose.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine, AzithromycinDrug
FMTVDM Planar, SPECT, PET
Hydroxychloroquine, DoxycyclineDrug
FMTVDM Planar, SPECT, PET
Hydroxychloroquine, ClindamycinDrug
FMTVDM Planar, SPECT, PET
Hydroxychloroquine, Clindamycin, Primaquine - low dose.Drug
FMTVDM Planar, SPECT, PET
Hydroxychloroquine, Clindamycin, Primaquine - high dose.Drug
FMTVDM Planar, SPECT, PET
RemdesivirDrug
FMTVDM Planar, SPECT, PET
TocilizumabDrug
FMTVDM Planar, SPECT, PET
FMTVDM Planar, SPECT, PET
Interferon-Alpha2BDrug
FMTVDM Planar, SPECT, PET
LosartanDrug
FMTVDM Planar, SPECT, PET
Convalescent SerumDrug
FMTVDM Planar, SPECT, PET
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated and Azithromycin 500 mg IV on day 1, followed by 250 mg IV on days 2-5 (to prevent bacterial superinfection ). Receives: Drug: Hydroxychloroquine, Azithromycin |
| Treatment 2 | Experimental | Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated and Doxycycline 100mg IV q 12 hrs with each dose given over 1 to 4-hours (to prevent bacterial superinfection ). Receives: Drug: Hydroxychloroquine, Doxycycline |
| Treatment 3 | Experimental | Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated Clindamycin 150-450 mg po q6 hours x 10 days OR 4800 mg IV daily - beginning with 150 mg initial rapid infusion, followed by continuous infusion q 24-hours for 7-days. Receives: Drug: Hydroxychloroquine, Clindamycin |
| Treatment 4 | Experimental | Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated Primaquine 200 mg po on day # 1. Clindamycin 150-450 mg po q6 hours x 10 days OR 4800 mg IV daily - beginning with 150 mg initial rapid infusion, followed by continuous infusion q 24-hours for 7-days. Receives: Drug: Hydroxychloroquine, Clindamycin, Primaquine - low dose. |
| Treatment 5 | Experimental | Primaquine 200 mg po on day # 1. Clindamycin 150-450 mg po q6 hours x 10 days OR 4800 mg IV daily - beginning with 150 mg initial rapid infusion, followed by continuous infusion q 24-hours for 7-days. This treatment arm is not available for intubated patients due to the absence of an IV form of Primaquine. Receives: Drug: Hydroxychloroquine, Clindamycin, Primaquine - high dose. |
| Treatment 6 | Experimental | Remdesivir 200 mg IV on day 1, followed by 100 mg IV qD for a total of 10-days. Receives: Drug: Remdesivir |
| Treatment 7 | Experimental | Tocilizumab 8mg/kg IV (not to exceed 800 mg) over 60-minutes. If clinical improvement is not noted, three additional doses may be administered at q 8-hour intervals from the initial infusion for a total of 4-doses maximum.
ANY PATIENT DEMONSTRATING CYTOKINE RELEASE SYNDROME WILL HAVE THIS TREATMENT ARM AUTOMATICALLY ADDED. Receives: Drug: Tocilizumab |
| Treatment 8 | Experimental | Methylprednisolone 125 mg IV every 6-hours for 3 days; then 125 mg IV every 12-hours for 2 days; then 125 mg IV daily for 2 days; then 60 mg IV daily for 2 days [with each infusion given over 30-minutes]; then Solumedrol dose pack to taper off steroids. Receives: Drug: Methylprednisolone |
| Treatment 9 | Experimental | Interferon alpha-2b 5 million units per nebulizer BID. Receives: Drug: Interferon-Alpha2B |
| Treatment 10 | Experimental | Losartan 25 mg po qD. IRB held due to questions about benefit. Receives: Drug: Losartan |
| Treatment 11 | Experimental | Convalescent Plasma 2-units ABO-compatible with antibody titer of 1:320 dilution. Each unit intravenously infused over 4-hours. Receives: Drug: Convalescent Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in FMTVDM Measurement with nuclear imaging.
Measured improvement in tissue as measured using FMTVDM
Measured: 72 hours
Secondary outcomes (2)
Ventilator status
Extubation
Measured: 7 days
Survival status
Self explanatory
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start11 Apr 2020
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoVid 19 PositiveStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Measurement of CoVid-19 pneumonia (CVP) and inflammation will be made using a patented method (FMTVDM #9566037 and adjunct USPTO submissions deemed covered by USPTO under the original patent #9566037). Following FMTVDM measurements, patients will be randomized into one of eleven treatment arms - others may be added as information becomes available. Forty-eight to 72-hours later - providing adequate time for treatment effect - FMTVDM will be repeated. Patients with improvement in FMTVDM will be maintained on their original treatment. FMTVDM measured treatment failure will result in a change to another arm of treatment. FMTVDM measurement showing no change will be treated by adding an additional treatment arm to patient care. Sequential FMTVDM studies will be carried out. Simultaneous Immune and ventilatory RX. Ventilatory support per ARDS protocol. Applicable blood tests and PCR will be included.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Camelot Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RM Fleming, MD, The Camelot Foundation
- Investigators
- Richard M Fleming, PhD, MD, JD, Study chair, FHHI-OI-Camelot;QME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349410
- Sponsor's protocol ID
- FMTVDM2020
- Acronym
- FMTVDM
- Status last verified
- Oct 2020
- First submitted
- 11 Apr 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through electronic request from approved individuals and institutions.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol
- ClinicalTrials.gov ID
- NCT04349410
- Acronym / sponsor ID
- FMTVDM / FMTVDM2020
- Conditions
- CoVid 19 Positive
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- The Camelot FoundationUniversity, hospital or other
- Study start
- 11 Apr 2020 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 16 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.
Diagnostic determination of disease and treatment responses has been limited to qualitative imaging, measurement of serum markers of disease, and sampling of tissue. In each of these instances, there is a built in error either due to sensitivity and specificity issues, clinician interpretation of results, or acceptance of the use of an indirect marker (blood test) of what is happening elsewhere in the body - at the tissue level.
The Fleming Method for Tissue and Vascular Differentiation and Metabolism (FMTVDM) using same state single or sequential quantification comparisons [1] provides the first and only patented test (#9566037) - along with the associated submitted patent applications ruled to be covered under #9566037 - that quantitatively measures changes in tissue resulting from inter alia a disease process. This includes inter alia coronary artery disease (CAD), cancer and infectious/inflammatory processes including CoVid-19 pneumonia (CVP) resulting from the metabolic and regional blood flow differences (RBFDs) caused by these diseases.
The purpose of this paper is to make clinicians and researchers aware of this proposed method for investigating the prevalence and severity of CVP - in addition to providing rapid determination of treatment response in each patient, directing treatment decisions; thereby reducing the loss of time, money, resources and patient lives.
Detailed description
FMTVDM - See Appendix A.
- Quantitatively calibrates the nuclear camera to guarantee that the measurements made by the camera are accurate, consistent and reproducible. This quantification is dependent upon the isotope being used, the camera and the timing sequence of image acquisition. Such calibration is NOT currently done and it is part of the patent. Studies have demonstrated that the lack of this quantitative calibration has resulted in up to 1/3 of the data being lost for SUV and qualitative interpretation; in addition to making quantification impossible.
- The patient presents in a fasting state - to eliminate digestive processes from interfering with blood flow distributions - and the differences in metabolic and regional blood flow differences (RBFDs) are enhanced with vasodilatory agents, shifting blood flow and isotope towards regions of greater blood flow and metabolism; enhancing isotope delivery, uptake and quantification.
- With a now quantitatively calibrated nuclear camera - in this instance a PLANAR camera - or SPECT/CT or PET/CT/MRI if specifically approved - to allow imaging to be done at patient's bedside reducing the use of hospital resources required for transport and decrease potential for patient complications resulting from a transport - image acquisition will occur for 10-minutes following peak enhancement effect of the vasodilatory agent and timed injection of the isotope based upon the enhancing agent. Regions-of-interest (ROIs) will drawn by the nuclear technologist - either at the bedside or in the nuclear laboratory - to provide FMTVDM measurements using software already present in the nuclear camera systems. Specific ROIs will be drawn of the right lung (total), left lung (total), mediastinum (thymus activity), and any specific areas where increased tracer uptake is noted.
- These FMTVDM measurements including MAXIMAL COUNTS +/- VARIANCE, provide the values of the most active pulmonary tissue resulting from the CoVid-19 infection and inflammatory response; just as it has previously been used for CAD and Cancer.
- From these FMTVDM measurements, the pulmonary tissue and the CoVid-19 infectious process results are placed on a Health-Spectrum showing where in the tissue transitioning process the patient is. The measurements also provide information about how rapidly the tissue is changing. FMTVDM provides the quantitative measurement of where the patient is at any point in time during their course of treatment and how they compare with other patients.
- Once the FMTVDM measurements have been obtained, treatment decisions can be made based upon serial changes in FMTVDM. Treatments outcomes are based upon FMTVDM measurements, including the maximum FMTVDM and the variance in those measurements. By comparing serial FMTVDM results, improvement or deterioration in the patient's health and the success or failure of the current treatment regimen is measured, providing patient-centered, patient-specific, patient-oriented and patient-directed decisions. Thus saving time, money, resources and lives - not to mention unnecessary side effects from treatment, which is not working.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 11
- Model description
- Measurement of CoVid-19 pneumonia (CVP) and inflammation will be made using a patented method (FMTVDM #9566037 and adjunct USPTO submissions deemed covered by USPTO under the original patent #9566037). Following FMTVDM measurements, patients will be randomized into one of eleven treatment arms - others may be added as information becomes available. Forty-eight to 72-hours later - providing adequate time for treatment effect - FMTVDM will be repeated. Patients with improvement in FMTVDM will be maintained on their original treatment. FMTVDM measured treatment failure will result in a change to another arm of treatment. FMTVDM measurement showing no change will be treated by adding an additional treatment arm to patient care. Sequential FMTVDM studies will be carried out. Simultaneous Immune and ventilatory RX. Ventilatory support per ARDS protocol. Applicable blood tests and PCR will be included.
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: Hydroxychloroquine, AzithromycinHydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated and Azithromycin 500 mg IV on day 1, followed by 250 mg IV on days 2-5 (to prevent bacterial superinfection ). |
| Treatment 2 | Experimental | Drug: Hydroxychloroquine, DoxycyclineHydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated and Doxycycline 100mg IV q 12 hrs with each dose given over 1 to 4-hours (to prevent bacterial superinfection ). |
| Treatment 3 | Experimental | Drug: Hydroxychloroquine, ClindamycinHydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated Clindamycin 150-450 mg po q6 hours x 10 days OR 4800 mg IV daily - beginning with 150 mg initial rapid infusion, followed by continuous infusion q 24-hours for 7-days. |
| Treatment 4 | Experimental | Drug: Hydroxychloroquine, Clindamycin, Primaquine - low dose.Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated Primaquine 200 mg po on day # 1. Clindamycin 150-450 mg po q6 hours x 10 days OR 4800 mg IV daily - beginning with 150 mg initial rapid infusion, followed by continuous infusion q 24-hours for 7-days. |
| Treatment 5 | Experimental | Drug: Hydroxychloroquine, Clindamycin, Primaquine - high dose.Primaquine 200 mg po on day # 1. Clindamycin 150-450 mg po q6 hours x 10 days OR 4800 mg IV daily - beginning with 150 mg initial rapid infusion, followed by continuous infusion q 24-hours for 7-days. This treatment arm is not available for intubated patients due to the absence of an IV form of Primaquine. |
| Treatment 6 | Experimental | Drug: RemdesivirRemdesivir 200 mg IV on day 1, followed by 100 mg IV qD for a total of 10-days. |
| Treatment 7 | Experimental | Drug: TocilizumabTocilizumab 8mg/kg IV (not to exceed 800 mg) over 60-minutes. If clinical improvement is not noted, three additional doses may be administered at q 8-hour intervals from the initial infusion for a total of 4-doses maximum. ANY PATIENT DEMONSTRATING CYTOKINE RELEASE SYNDROME WILL HAVE THIS TREATMENT ARM AUTOMATICALLY ADDED. |
| Treatment 8 | Experimental | Drug: MethylprednisoloneMethylprednisolone 125 mg IV every 6-hours for 3 days; then 125 mg IV every 12-hours for 2 days; then 125 mg IV daily for 2 days; then 60 mg IV daily for 2 days [with each infusion given over 30-minutes]; then Solumedrol dose pack to taper off steroids. |
| Treatment 9 | Experimental | Drug: Interferon-Alpha2BInterferon alpha-2b 5 million units per nebulizer BID. |
| Treatment 10 | Experimental | Drug: LosartanLosartan 25 mg po qD. IRB held due to questions about benefit. |
| Treatment 11 | Experimental | Drug: Convalescent SerumConvalescent Plasma 2-units ABO-compatible with antibody titer of 1:320 dilution. Each unit intravenously infused over 4-hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Hydroxychloroquine, AzithromycinFMTVDM Planar, SPECT, PET | Drug | Treatment 1 |
| Hydroxychloroquine, DoxycyclineFMTVDM Planar, SPECT, PET | Drug | Treatment 2 |
| Hydroxychloroquine, ClindamycinFMTVDM Planar, SPECT, PET | Drug | Treatment 3 |
| Hydroxychloroquine, Clindamycin, Primaquine - low dose.FMTVDM Planar, SPECT, PET | Drug | Treatment 4 |
| Hydroxychloroquine, Clindamycin, Primaquine - high dose.FMTVDM Planar, SPECT, PET | Drug | Treatment 5 |
| RemdesivirFMTVDM Planar, SPECT, PET | Drug | Treatment 6 |
| TocilizumabFMTVDM Planar, SPECT, PET | Drug | Treatment 7 |
| MethylprednisoloneFMTVDM Planar, SPECT, PET | Drug | Treatment 8 |
| Interferon-Alpha2BFMTVDM Planar, SPECT, PET | Drug | Treatment 9 |
| LosartanFMTVDM Planar, SPECT, PET | Drug | Treatment 10 |
| Convalescent SerumFMTVDM Planar, SPECT, PET | Drug | Treatment 11 |
Primary outcome
Improvement in FMTVDM Measurement with nuclear imaging.
Time frame: 72 hours
Measured improvement in tissue as measured using FMTVDM
2 secondary outcomes
Ventilator status
Time frame: 7 days
Survival status
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- FMTVDM Patent # 9566037Link provided by the sponsor.
- The Critical Importance of Quantifying Tissue Change instead of using qualitative or semi-quanitified results.Link provided by the sponsor.
- FMTVDM quantification for coronary artery disease and inflammationLink provided by the sponsor.
- FMTVDM quantification.Link provided by the sponsor.
- Infection and Inflammation reversal by treatment of pathogens with associated reductions in IL-6.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be made available through electronic request from approved individuals and institutions.
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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.
Richard M Fleming, PhD, MD, JD study chair
FHHI-OI-Camelot;QME
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydroxychloroquine, Azithromycin, Hydroxychloroquine, Doxycycline and Hydroxychloroquine, Clindamycin in people with CoVid 19 Positive, run by The Camelot Foundation 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 12 Nov 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in FMTVDM Measurement with nuclear imaging. (time frame: 72 hours). 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 12 Nov 2020.