COVID-19: The Clinical Studies Problem

According to our medical experts, clinical studies are the gold standard of medical information. Nuggets of truth in mountains of claims. There are more than a few problems, ranging from red-herrings to fools gold, to claims of “ that’s not real gold,” and “ gold does not exist “, to only occasionally a nugget. Usually, no gold is found. Can anyone name any cure found in any clinical study of ANY non-infectious disease? No. Cured is not define for non-infectious diseases.

COVID-19 has been with us for almost a year or more, depending on which theory or conspiracy theory you ascribe to. According to WorldMeters.Info, there have been over 60 million CASES. Over 40 million patients are reported as RECOVERED, over one million deaths.

But, how many are CURED? Officially — none. Not a single one. There are cured claims. Donald Trump claims to be cured, but apparently, nobody cares — and we don’t know for sure. There is no officially recognized tests for cured outside of a clinical study. There are mountains of claims of treatments that can cure. All are dismissed. Every claim is easily countered by the Clinical Studies Mantra “ this claim has yet to be proven in a clinical study.

Four Thousand, Nineteen COVID-19 Clinical Studies

So, let’s check that theory. What do the clinical studies actually tell us? ClinicalTrials.gov contains documents of over 350,000 clinical trials in 219 countries.

A search for trials about COVID-19 as of November 27, 2020 shows 4019 studies. A few days later, on November 29, it shows 4029. Today, it shows 4086 studies.

Only 76 Studies Contain the word CURE

A search for COVID-19 in 4019 studies for CURE shows only 76 studies. Less than 2 percent of COVID-19 clinical trials contain the word “cure”. Over 98 percent do not. What’s up with that? But wait. It gets worse…

Of those 76 studies, 57 make no attempt to Cure COVID

Of the 76 studies of COVID-19 containing the word CURE or CURABLE, most do not define cured and do not test for cured.

Six do not actually contain the word cure in any variation. Why does the ClinicalTrials.Gov search find them? I have no idea. Three studies use the word cure in the title or contents, but not in the study, Marketing cure but not studying it.

Four are titled studies of CURED PATIENTS (even though world stats report no cured cases. In three, cured is defined. Disease consequences are studied as opposed to cures. Two more are titled studies of RECOVERED PATIENTS, avoiding use of the word” cure. Five studies test the use of plasma from CURED patients as a treatment for COVID-19 pneumonia (cured not defined nor tested). Three studies about other disease treatments affected by COVID, using the word cure where the more accurate word is treatment.

Four studies use the word cure in reference to other diseases, not COVID-19. Four Studies are about curing diseases caused by COVID-19, not about curing COVID-19. Two meta-studies measure CURED vs Dead, without researching cures.

Thirteen use the word cure, without a definition of cure or test for cured. These studies cannot find cures — they are out of scope.

Nine studies contain the word cure in a cure denial phrase, without any evidence much less proof: always made without a definition of cured, so metimes it’s not even clear which disease is the subject of the word cure.

Only 19 of 4019 COVID-19 studies measure Cure

Thirteen of those nineteen studies define cured as a cure of the viral infection, not the entire disease.

Of the total 4019 clinical studies about COVID-19, only 6 refer to a cure of the disease. Most of those use the phrase “patients cured” (without a clear definition) as opposed to “disease cured.”

Of 4019 studies, only 0.1 percent are studies of COVID-19 cured. No two of the six clinical studies use the same definition of cured. See Research note #10 below for details.

Why does this happen?

There are several reasons why there is no agreed definition of cure in clinical studies of COVID-19. The first is simply confusion about the definition of the disease.

There is an official name of the disease COVID-19, although the press pays it little mind. According to the World Health Organization, the virus (not the disease) is named: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) the disease it causes is named: coronavirus disease (COVID-19).

SARS-CoV-2, the virus, is not COVID-19. However, the World Health Organization’s ICD11, the International Classification of Diseases Version 11, contains codes for COVID-19, for SARS-CoV-2, for Post COVID-19 Condition, for COVID-19 with pneumonia. The goals of the ICD11 are to be inclusive of any condition a doctor in any country might diagnose and report — as opposed to being strictly scientific.

The Virus — SARS-CoV-2

In most diseases, asymptomatic means no disease — so an asymptomatic SARS-CoV-2 infection would not be considered a case of COVID-19. An asymptomatic case dose not need a cure. However, tracking COVID-19 uses a different model, where asymptomatic infections are reported as COVID-19 disease.

Officially, the disease includes all medical conditions caused by the virus. Clinical studies that aim to cure the SARS-CoV-2 infection and measure their success, are not studying COVID-19 cures.

The Disease — COVID-19

The signs and symptoms of the COVID-19 can range from asymptomatic, to fever, dry cough, tiredness, aches and pains, sore throat, diarrhea, conjunctivitis, headache, loss of taste or smell, a rash on skin, discoloration of fingers and toes, difficulty breathing, shortness of breath, chest pain or pressure, loss of speech or movement, possible damage to various internal organs including the brain, and possibly death. To find and document a cure for COVID-19, do we need to alleviate all of these signs and symptoms? In some cases? In every case? Or are some signs and symptoms, like loss of smell, considered separate diseases, not necessarily part of a COVID-19 cure?

The Pandemic

The COVID pandemic includes other diseases. Several diseases are now recognized as caused by COVID-19, including COVID-19 Pneumonia (has a disease code in the ICD11) and COVID-19 PTSD (does not yet have a disease code in the ICD11). There are also discussions of — although little research into — diseases caused by our reactions to the pandemic, like loss of income, poverty, even suicide. Do these diseases require independent cures, or is COVID-19 the disease only cured when these diseases are cured as well?

There are no clear answers. No one is working to find the answers. COVID-19 cured is not medically defined. COVID-19 Pneumonia can be medically defined — we have useful definitions of cured for pneumonia infections. COVID-19 PTSD cured is not medically defined. There being no medical test for PTSD cured.

(most) Clinical Studies Are Not Designed to Cure

The clinical studies model is not designed to find cures. Clinical studies are designed to test the effectiveness and safety of drugs — in most cases, to test the effectiveness and safety of drugs that do not cure. Most clinical studies, for any treatment, do not define cured and do not test for cured. The goal is to test a product, it’s safety and viability for marketing, not to cure a disease.

Clinical Studies are Slow

As of today ClinicalStudies.gov shows 4086 COVID-19 studies. Only twelve studies containing the word cure are COMPLETED. Only one actually contains a test for cured — infection cured, not COVID-19 cured. No results have been posted on ClinicalStudies.gov. See Research #12 below.

Even though the patient time in a clinical study is generally very small — usually less than three weeks for COVID-19 studies, the actual studies take enormous amounts of time — even after their completion dates have passed.

Have any cures been found? None. Have patient’s been cured? Over 40 million are recovered. Not one cured is recognized.

No clinical study can Evaluate (prove or disprove) a Cure Claim

When someone — a patient, a doctor, a priest or even a saint claims a cure, no clinical study can prove the cure is valid, nor invalid. We might find evidence in clinical studies, but not proofs. Proof is found in cases, not in statistical studies.

There is no point in waiting for clinical studies to test the cured. It doesn’t happen. Clinical studies are not about the science of disease. Each clinical study is an anecdote about a specific treatment used on a specific (usually small) set of patients in a very controlled situation, over a short time period, designed to approve a product for the market.

Marketing goals are far more important than cure goals.

No clinical study can prove — or disprove — Donald Trumps cured status, much less what, if anything, cured him.

If we want to find cures, we need to study cure, not medicines, not treatments. Almost every case of the common cold is cured. But no clinical study can find a cure for the common cold. COVID-19? Same same.

To your health, Tracy
Founder: Healthicine

This post was written based on the concepts of illness and disease explored in the books: The Science of Cure, The Elements of Cure and an expansion of the concepts discussed in the book COVID-19: Defining Cured.

Research Notes:

1. Cure appears in the title of one study, COVID19 (VA-CURES-1( VA-CURES-1) but the study measures “ time in days to recovery” — not “ time in days to cure.” Like another 2 studies, the word cure is used in the title, perhaps as a marketing term, but does not appear in the content of the study.

2. One translation error (from Italian) and another Clinic name “cure” not translated to English “care”

  • needing admission to an Intensive Cure Unit
  • Unità’ Complesse di cure primarie (UCCP), ASP Catanzaro

3. Cured defined as “ did not die

4. Cure Denial:

  • says: currently, there is no cure for COVID-19, except for supportive treatments.
  • Currently, no specific drugs or vaccines are available to cure the patients with COVID-19 pneumonia
  • As there is no specific cure in the treatment of COVID-19
  • There is an urgent need for an effective regimen to cure this illness
  • COVID-19 may cause severe pneumonitis… to date there is no effective cure. (ARDS in Patients With COVID-19)
  • There is presently no cure for the COVID-19 viral disease
  • humanity has yet to find a cure or a vaccine for the treatment of patients
  • after intensive-care with… find solutions to cure them or decrease their (the complications) impact on patient’s life
  • screen patients at risk of pulmonary embolism and to set up a curative anticoagulation.

5. Three studies about other disease treatments affected by COVID, uses the word cure where a more accurate word is treatment:

  • Proportion of patients with change in the number of (cancer) cures administered
  • Change in the modalities of administration of antibiotics cures (for cystic fibrosis)
  • Enoxaparin sodium curative at a dose of 100 IU/kg/12h subcutaneously (SC) not to exceed a dose of 100 mg/12 hours

6. Cures of other Diseases, not COVID-19

  • Viral hepatitis C cured for more than 12 months
  • preventive or curative therapeutic response (for ophthalmologic problems)
  • that evidence of CRS (Cytokines release syndrome) can be cured with glucocorticoids,
  • curative surgery (with or without chemotherapy), chemotherapy only or exclusive supportive care (for pancreatic cancer)

7. There are, for example, 40 studies of favipiravir. Only few contain the word cure in the study document. Two are in agreement in the definition of cure:

Some provide a different definition.

  • a study of Favipiravir, tests cured as “2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing
  • two studies of Favipiravir and lactoferrin, tests cured as “2 SARS-COV-2 PCR samples negative with 48 hours apart

8. Viral Infection Cure

  • a study of Ivermectin as an add-on therapy measures cure as “patients who had symptoms free and two successive readings of negative PCR swab.
  • 6 studies of “virologically cured” (not defined in study document). eg. infection cured — but not COVID-19 cured.
  • Virology cure, “COVID-19 serology testing
  • Documented virological clearance in 2 samples at least 24 hours apart.
  • cured assessed RT-PCR for SARS CoV-2, without clinical symptoms and no radiological signs assessed by chest X ray
  • If the result of RT-PCR test is negative, then 24 hours apart another RT-PCR test will be done. Subject to 2 consecutive negative tests patient will be declared as cured
  • rate of virological cure by Rt -PCR for COVID -19using the triple therapy as compared to standard treatment [ Time Frame: for every case must be done after 2 weeks from the start of treatment. ]
  • The cure rate of 2019-nCoV. [ Time Frame: 6 months ]

9. Thirteen use the word cure, without a definition of cure or test for cured and without curing the disease:

  • the role of ivermectin in the cure of COVID 19 patients (ivermectin only addresses the infection)
  • a traditional plant believed to cure several diseases, including alleviating COVID-19
  • Patients cured at 15 days
  • We try to establish the criteria for clinical cure and the early predictive model of COVID-19 progression
  • from a person who has cured from this disease, could be applied to cure other patients more rapidly.
  • The introduction of early curative anticoagulation
  • preventative and curative measures to control the spread of virus.
  • preventive or curative anticoagulant therapy could be considered
  • at the forefront of future curative therapy
  • Its cure is essentially dependent on the patient’s immunity
  • Evaluation standard of comprehensive curative effect
  • during the infection and after being cured
  • Frequency of clinical cure on day 10 from the start of therapy

10. Six studies refer to more than just the infection, actually studying
COVID-19, the disease: (comments in brackets)

  • patients cured (not defined) at the end of the study. The healing criteria are defined clinically as: disappearance of clinical signs of acute respiratory infection absence of fever
  • clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test (not defined in study document).
  • number of days to cure from COVID-19 disease (cure and disease not defined)
  • patients cured from the Wuhan epidemic (cured not defined)
  • clinical cure incidence in 14 days [ Time Frame: 14 days ] The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed. (only recognizes cures if no alternative treatment used?)
  • One study measured a large number of variables, including cured (not defined).

11. Some studies are not actually about the infection SARS-CoV-2, and not about
COVID-19, they are about consequences of COVID-19. For example COVID-19 associated pneumonia. Cured is defined differently: These four Studies are about curing other diseases caused by COVID-19, not about curing COVID-19.

  • cured, assessed by PCR in addition to chest CT scan
  • Clinical recovery, negative COVID-19 nucleic acid results and CT (pneumonia) recovery among infected patients
  • cure: Number of patients with resolution of fever, cough, and need for ventilatory or oxygen support.
  • patients who will present this dysregulation of the curative response (LUNG FIBROTIC CHANGES

12 Completed studies Containing the word Cure

  • Antibody Detection in COVID-19 Cured Patients (not cure)
  • Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (not cure)
  • Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment (viral infection cure)
  • Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19 (not cure)
  • Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic — COVID19
  • Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients (no cure test)
  • Efficacy and Safety of Corticosteroids in COVID-19 (improvement not cure)
  • Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2 (not cure)
  • TCM Differentiation and Treatment Protocol of COVID-19 (no test for cured)
  • Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19) (no test for cured)
  • Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment (no test for cured)

Originally published at http://healthicine.org.

Author: A Theory of Cure, The Elements of Cure, Author: Healthicine, the Arts and Sciences of Health and Healthiness