COVID-19Phase 2NCT04391712
Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
A Phase 2 study testing MLS Laser and Regular Inpatient Medical Care in people with COVID-19, run by Lowell General Hospital at 1 site in United States.
Trial summary
The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- MLS Laser and Regular Inpatient Medical Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2020to 16 Jul 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 positive
- Pulmonary compromise requiring oxygen support of approximately 2-6 liters
- Able to self prone, or support in self-sitting position
Who cannot join
- Ventilator management
- Patients with autoimmune disorders or inflammatory conditions not related to COVID-19
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Lowell General Hospital
Lowell, Massachusetts, 01854
About this study
Official title: Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.
Read the detailed description
Participants will be randomized into treatment vs. control group. Both groups will receive regular inpatient medical treatment. Participants in the experimental arm will receive laser treatments once daily for 4 days. Treatments will be delivered to the patients in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard nursing protocols would be used to identify participant's pulmonary status throughout treatment.
- Conditions
- COVID-19
- Being tested
- MLS Laser, Regular Inpatient Medical Care
- Keywords
- COVID, Laser, Pulmonary
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLS LaserDevice
Treatments will be delivered to the participants days 1-4, in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz.
Regular Inpatient Medical CareOther
Regular inpatient medical care
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will receive MLS laser treatment along with regular inpatient medical care. Receives: Device: MLS Laser |
| Control Group | Active comparator | Participants will receive regular inpatient medical care. Receives: Other: Regular Inpatient Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Disposition Post treatment
ICU on vent, ICU not requiring ventilation, Discharge to Rehab requiring assistance, Discharge to Home unable to perform ADL's, Discharge to Home able to perform ADL's
Measured: 7 days
oxygenation
Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol
Measured: Daily for 4 days
IL-6 levels
The change in pre treatment levels and 24 hours post final treatment
Measured: First four days of trial
Chest Xray radiographic results
Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
Measured: 7 Days
Brescia-COVID Respiratory Severity Scale
The change in pretreatment and post treatment BCRSS will be evaluated
Measured: 7 days
SMART-COP Score
The change in pretreatment and post treatment scores will be evaluated
Measured: 7 days
PSI Score
The change in pretreatment and post treatment scores will be evaluated
Measured: 7 days
CRP levels
The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start30 Apr 2020
- Primary completion15 May 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will utilize a randomized parallel assignment
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lowell General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Sigman, MD, Lowell General Hospital
- Investigators
- Scott Sigman, MD, Principal investigator, Lowell General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391712
- Sponsor's protocol ID
- 2020.01
- Status last verified
- Aug 2020
- First submitted
- 4 May 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04391712
- Acronym / sponsor ID
- 2020.01
- Conditions
- COVID-19
- Keywords
- COVID, Laser, Pulmonary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lowell General HospitalUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 18 May 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 aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.
Detailed description
Participants will be randomized into treatment vs. control group. Both groups will receive regular inpatient medical treatment. Participants in the experimental arm will receive laser treatments once daily for 4 days. Treatments will be delivered to the patients in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard nursing protocols would be used to identify participant's pulmonary status throughout treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will utilize a randomized parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: MLS LaserParticipants will receive MLS laser treatment along with regular inpatient medical care. |
| Control Group | Active comparator | Other: Regular Inpatient Medical CareParticipants will receive regular inpatient medical care. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COVID-19 positive
- Pulmonary compromise requiring oxygen support of approximately 2-6 liters
- Able to self prone, or support in self-sitting position
Key exclusion criteria (3 listed)
- Ventilator management
- Patients with autoimmune disorders or inflammatory conditions not related to COVID-19
- Pregnant women
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 |
|---|---|---|
| MLS LaserTreatments will be delivered to the participants days 1-4, in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. | Device | Experimental |
| Regular Inpatient Medical CareRegular inpatient medical care | Other | Control Group |
Primary outcome
Patient Disposition Post treatment
Time frame: 7 days
ICU on vent, ICU not requiring ventilation, Discharge to Rehab requiring assistance, Discharge to Home unable to perform ADL's, Discharge to Home able to perform ADL's
oxygenation
Time frame: Daily for 4 days
Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol
IL-6 levels
Time frame: First four days of trial
The change in pre treatment levels and 24 hours post final treatment
Chest Xray radiographic results
Time frame: 7 Days
Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
Brescia-COVID Respiratory Severity Scale
Time frame: 7 days
The change in pretreatment and post treatment BCRSS will be evaluated
SMART-COP Score
Time frame: 7 days
The change in pretreatment and post treatment scores will be evaluated
PSI Score
Time frame: 7 days
The change in pretreatment and post treatment scores will be evaluated
CRP levels
Time frame: 7 days
The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated
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 5 Aug 2020.
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.
Scott Sigman, MD principal investigator
Lowell General Hospital
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 MLS Laser and Regular Inpatient Medical Care in people with COVID-19, run by Lowell General Hospital 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 3 inclusion and 3 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 5 Aug 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 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 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?
Patient Disposition Post treatment (time frame: 7 days). The study lists 8 primary outcomes in all. 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 5 Aug 2020.